Devices › Device, hemostasis, vascular
Device brand name · Angio-seal device
6f Angio-Seal Evolution: medical device reports filed with FDA
204 reports name it, 2008–2014. Manufacturer given most often on reports: St Jude Medical. Product code MGB.
- 204
- device reports naming the brand
- 0% of all MAUDE reports · about 12 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 0%
- classified as malfunction
- 16.4% across the product code
- 3.9%
- classified as death, as reported
- 8 reports · not verified by FDA
204 medical device reports received by FDA name the brand "6f Angio-Seal Evolution" (angio-seal device); the manufacturer given most often on reports is St Jude Medical; received from December 2008 to August 2014. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and 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 (93.1%), death (3.9%) and other (2.5%); 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 insufficient device problem information (41.2%), malposition of device (5.4%) and device operates differently than expected (4.9%). The patient problems coded most often are hemorrhage/blood loss/bleeding, hematoma and pain. 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
No report naming 6f Angio-Seal Evolution was received in the five years to August 2026; the latest was received in August 2014.
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 |
|---|---|---|---|
| Insufficient device problem information | 84 | 41.2% | 3% |
| Malposition of device | 11 | 5.4% | 3% |
| Device operates differently than expectedthe device behaved unexpectedly | 10 | 4.9% | 13.6% |
| Breakthe device broke | 8 | 3.9% | 1.5% |
| Device remains implanted | 8 | 3.9% | 0.7% |
| Difficult or delayed positioning | 8 | 3.9% | 1.1% |
| Device dislodged or dislocated | 7 | 3.4% | 0.1% |
| Explanted | 5 | 2.5% | 0.7% |
| Improper or incorrect procedure or method | 5 | 2.5% | 4.6% |
| Migration or expulsion of device | 4 | 2% | 0.3% |
| Activation, positioning or separation problem | 3 | 1.5% | 1.7% |
| Device, removal of (non-implant) | 3 | 1.5% | 0.5% |
| Difficult to removethe device was hard to remove | 3 | 1.5% | 4.2% |
| Device or device fragments location unknown | 2 | 1% | 0% |
| Difficult to insertthe device was hard to insert | 2 | 1% | 2.2% |
| Leak/splashthe device leaked | 2 | 1% | 0.1% |
| Sticking | 2 | 1% | 0.4% |
| Bent | 1 | 0.5% | 0.3% |
| Component missing | 1 | 0.5% | 0.4% |
| Detachment of device component | 1 | 0.5% | 3.4% |
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 | 69 | 33.8% |
| Hematomaa collection of blood under the skin or in tissue | 62 | 30.4% |
| Painpain, site not specified | 47 | 23% |
| Pseudoaneurysm | 35 | 17.2% |
| Occlusion | 18 | 8.8% |
| Therapy/non-surgical treatment, additional | 18 | 8.8% |
| Hospitalization required | 17 | 8.3% |
| Bleeding | 13 | 6.4% |
| Low blood pressure/ hypotension | 12 | 5.9% |
| Swellingswelling | 12 | 5.9% |
| Deaththe patient died; cause not stated by this term | 11 | 5.4% |
| Surgical procedure | 10 | 4.9% |
| Vascular system (circulation), impaired | 10 | 4.9% |
| Loss of pulse | 8 | 3.9% |
| Treatment with medication(s) | 7 | 3.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | 6f Angio-Seal Evolution | Product code MGB | All MAUDE reports |
|---|---|---|---|
| Reports | 204 | 124,366 | 26,136,888 |
| Share of that pool | — | 0.2% | 0% |
| Classified as death, per 1,000 reports | 39 | 6 | 9 |
| Classified as injury | 93.1% | 82.5% | 36.2% |
| Classified as malfunction | 0% | 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 Suture-Mediated Closure and Repair System | 16,441 | 22 | 0% |
| 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% |
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 6f Angio-Seal Evolution reports
How many FDA reports name 6f Angio-Seal Evolution?
204 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (93.1%), death (3.9%) and other (2.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (41.2%), malposition of device (5.4%), device operates differently than expected (4.9%), break (3.9%) and device remains implanted (3.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that 6f Angio-Seal Evolution 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.