Device brand name · Vascular clamp
Guidant 4 5mm Heartstring Proximal Seal: medical device reports filed with FDA
615 reports name it, 2003–2008. Manufacturer given most often on reports: Guidant Cardiac Surgery. Product code DXC.
- 615
- device reports naming the brand
- 0% of all MAUDE reports · about 26 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 90.4%
- classified as malfunction
- 88% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 615 reports that name the brand "Guidant 4 5mm Heartstring Proximal Seal" (vascular clamp), received between March 2003 and June 2008; the manufacturer given most often on reports is Guidant Cardiac Surgery. Spellings of one product vary from report to report.
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 malfunction (90.4%) and injury (9.4%); across all clamp, vascular reports (product code DXC) death is recorded in 0.6% and malfunction in 88%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are replace (71.2%), crack (60%) and positioning failure (29.6%). The patient problems coded most often are surgical procedure aborted/stopped, surgical procedure and dural tear. 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 Guidant 4 5mm Heartstring Proximal Seal was received in the five years to August 2026; the latest was received in June 2008.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 13,077 reports carrying product code DXC. 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 |
|---|---|---|---|
| Replace | 438 | 71.2% | 18.9% |
| Crackthe device cracked | 369 | 60% | 17.5% |
| Positioning failure | 182 | 29.6% | 13.7% |
| Unraveled material | 57 | 9.3% | 3.4% |
| Sticking | 24 | 3.9% | 2.9% |
| Difficult to removethe device was hard to remove | 21 | 3.4% | 1.6% |
| Device, removal of (non-implant) | 13 | 2.1% | 0.8% |
| Other (for use when an appropriate device code cannot be identified) | 13 | 2.1% | 1% |
| Seal, defective | 7 | 1.1% | 0.3% |
| Image orientation incorrect | 4 | 0.7% | 0% |
| Device damaged prior to usethe device was damaged before use | 3 | 0.5% | 0% |
| Device expiration issue | 3 | 0.5% | 0.1% |
| Leak/splashthe device leaked | 3 | 0.5% | 1.1% |
| Malfunction | 3 | 0.5% | 0.3% |
| Repair | 3 | 0.5% | 0.2% |
| Tears, rips, holes in device, device material | 3 | 0.5% | 0.1% |
| Device issuea problem with the device | 2 | 0.3% | 0.5% |
| Device maintenance issue | 2 | 0.3% | 0% |
| Material separation | 2 | 0.3% | 0.5% |
| Out-of-box failure | 2 | 0.3% | 0.2% |
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 |
|---|---|---|
| Surgical procedure aborted/stopped | 63 | 10.2% |
| Surgical procedure | 16 | 2.6% |
| Dural tear | 14 | 2.3% |
| Surgical procedure, additional | 14 | 2.3% |
| Therapy/non-surgical treatment, additional | 10 | 1.6% |
| No patient involvement | 9 | 1.5% |
| Calcium deposits/calcification | 6 | 1% |
| Failure to anastomose | 6 | 1% |
| Bleeding | 4 | 0.7% |
| Foreign body, removal of | 4 | 0.7% |
| Anastomosis | 1 | 0.2% |
| Hypovolemic shock | 1 | 0.2% |
| Intimal dissection | 1 | 0.2% |
| Other (for use when an appropriate patient code cannot be identified) | 1 | 0.2% |
| Surgery, prolonged | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Guidant 4 5mm Heartstring Proximal Seal | Product code DXC | All MAUDE reports |
|---|---|---|---|
| Reports | 615 | 13,077 | 26,136,888 |
| Share of that pool | — | 4.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 6 | 9 |
| Classified as injury | 9.4% | 10.7% | 36.2% |
| Classified as malfunction | 90.4% | 88% | 62.3% |
| Filed by the manufacturer | 100% | 97% | 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 DXC
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Guidant 4 5 Mm Heartstring Proximal Seal | 2,617 | 0 | 0% |
| Tr Band | 1,273 | 571 | 0.2% |
| Tr Band Radial Compression Device | 292 | 1 | 0% |
| Endoclamp Aortic Catheter | 169 | 0 | 2.4% |
| Acrobat-i Stabilizer | 424 | 37 | 0.2% |
| VasoView Hemopro 2 | 6,633 | 686 | 0% |
| Vaso View Hemopro | 1,838 | 0 | 0.1% |
| Resolution Clip Device | 1,596 | 0 | 0.3% |
| Vasoview 6 Pro | 328 | 8 | 0% |
| Vasoview 7 Xb | 388 | 0 | 0% |
| HemoPro2 Extension Cable | 539 | 30 | 0% |
| Karl Storz | 633 | 0 | 2.1% |
| Vasoview Hemopro 2 Evh System | 259 | 0 | 0% |
| Hemopro2 Adaptor | 167 | 14 | 0% |
| Vasoview Hemopro 2 With Vasoshield | 176 | 0 | 0% |
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 Guidant 4 5mm Heartstring Proximal Seal reports
How many FDA reports name Guidant 4 5mm Heartstring Proximal Seal?
615 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?
malfunction (90.4%) and injury (9.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
replace (71.2%), crack (60%), positioning failure (29.6%), unraveled material (9.3%) and sticking (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 Guidant 4 5mm Heartstring Proximal Seal 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.