Devices › Device, hemostasis, vascular
Device brand name · Suture mediated closure
Perclose ProStyle Suture-Mediated Closure and Repair System: medical device reports filed with FDA
16,441 reports name it, 2021–2026. Manufacturer given most often on reports: Abbott Vascular. Product code MGB.
- 16,441
- device reports naming the brand
- 0.1% of all MAUDE reports · about 3,237 a year
- 22
- reports, 12 months to August 2026
- 0 in the 12 months before
- 1.2%
- classified as malfunction
- 16.4% across the product code
- 0%
- classified as death, as reported
- 8 reports · not verified by FDA
16,441 medical device reports received by FDA name the brand "Perclose ProStyle Suture-Mediated Closure and Repair System" (suture mediated closure); the manufacturer given most often on reports is Abbott Vascular; received from June 2021 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
22 reports arrived in the 12 months to August 2026, with none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (98.8%) and malfunction (1.2%); across all device, hemostasis, vascular reports (product code MGB) death is recorded in 0.6% and malfunction in 16.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are failure to cycle (77.4%), material separation (8.7%) and off-label use (5%). The patient problems coded most often are hemorrhage/blood loss/bleeding, obstruction/occlusion and hematoma. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 124,366 reports carrying product code MGB. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Failure to cycle | 12,730 | 77.4% | 28.4% |
| Material separation | 1,427 | 8.7% | 6.9% |
| Off-label use | 822 | 5% | 1.5% |
| Improper or incorrect procedure or method | 556 | 3.4% | 4.6% |
| Difficult to open or close | 498 | 3% | 1.6% |
| Malposition of device | 414 | 2.5% | 3% |
| Difficult to removethe device was hard to remove | 367 | 2.2% | 4.2% |
| Entrapment of device | 359 | 2.2% | 1.6% |
| Obstruction of flow | 339 | 2.1% | 1.1% |
| Insufficient device problem information | 247 | 1.5% | 3% |
| Patient device interaction problem | 237 | 1.4% | 1.5% |
| Difficult to insertthe device was hard to insert | 131 | 0.8% | 2.2% |
| Product quality problem | 124 | 0.8% | 0.4% |
| Difficult to advance | 120 | 0.7% | 0.6% |
| Mechanical jam | 120 | 0.7% | 1.3% |
| Failure to advance | 95 | 0.6% | 0.9% |
| Breakthe device broke | 84 | 0.5% | 1.5% |
| Deformation due to compressive stress | 83 | 0.5% | 0.3% |
| Failure to fire | 71 | 0.4% | 1.2% |
| Retraction problem | 64 | 0.4% | 1.3% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Hemorrhage/blood loss/bleeding | 119 | 0.7% |
| Obstruction/occlusion | 101 | 0.6% |
| Hematomaa collection of blood under the skin or in tissue | 71 | 0.4% |
| Vascular dissection | 55 | 0.3% |
| Foreign body in patientpart of a device left in the patient | 52 | 0.3% |
| Painpain, site not specified | 52 | 0.3% |
| Thrombosis/thrombus | 32 | 0.2% |
| Pseudoaneurysm | 27 | 0.2% |
| Swelling/ edema | 24 | 0.1% |
| Perforation of vessels | 23 | 0.1% |
| Inflammationinflammation | 9 | 0.1% |
| Ischemia | 7 | 0% |
| Shockshock, a collapse of the circulation | 7 | 0% |
| Low blood pressure/ hypotension | 4 | 0% |
| Diminished pulse pressure | 3 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Perclose ProStyle Suture-Mediated Closure and Repair System | Product code MGB | All MAUDE reports |
|---|---|---|---|
| Reports | 16,441 | 124,366 | 26,136,888 |
| Share of that pool | — | 13.2% | 0.1% |
| Classified as death, per 1,000 reports | 0 | 6 | 9 |
| Classified as injury | 98.8% | 82.5% | 36.2% |
| Classified as malfunction | 1.2% | 16.4% | 62.3% |
| Filed by the manufacturer | 100% | 97.5% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code MGB
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Perclose Proglide 6f Suture Mediated Closure Smc System | 46,236 | 0 | 0.3% |
| Perclose ProStyle | 12,935 | 2,308 | 0.1% |
| Starclose Se Vascular Closure System | 6,432 | 0 | 0.4% |
| Perclose ProGlide | 3,554 | 653 | 0.9% |
| Angio-Seal | 2,523 | 902 | 0.8% |
| Exoseal | 2,441 | 1,161 | 0% |
| 6f Angio-Seal Vip Vascular Closure Device Ous | 1,818 | 0 | 0.3% |
| Mynx Control | 1,766 | 768 | 0.1% |
| Starclose Vascular Closure System | 1,880 | 8 | 1.2% |
| 6f Angio-Seal Vip Vascular Closure Device Us | 1,617 | 0 | 0.2% |
| Mynxgrip | 1,254 | 422 | 0.3% |
| Prostar Xl Suture-Mediated Closure | 1,239 | 0 | 3.1% |
| Mynxgrip Vascular Closure Device 6f-7f | 1,171 | 0 | 0.6% |
| 8f Angio-Seal Vip Vascular Closure Device Ous | 1,056 | 0 | 0.3% |
| 6f Angio-Seal Vascular Closure Device Vip | 1,055 | 0 | 4% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Perclose ProStyle Suture-Mediated Closure and Repair System reports
How many FDA reports name Perclose ProStyle Suture-Mediated Closure and Repair System?
16,441 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 22 in the latest 12 months.
What kinds of events are reported?
injury (98.8%) and malfunction (1.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to cycle (77.4%), material separation (8.7%), off-label use (5%), improper or incorrect procedure or method (3.4%) and difficult to open or close (3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Perclose ProStyle Suture-Mediated Closure and Repair System was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.