MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2007-04-10 for SHELHIGH VASCUPATCH SHP-555-CRT17 manufactured by Shelhigh.
[18242494]
User facility notified the fda of the event several months (approx 6 mo) after the event. User facility did not notify mfr. Pt received 1x7 cm shelhigh pericardial patch for closure of carotid arteriotomy. Two months postop, pt experienced bleeding pseudoaneurysm. Blood cultures were obtained and were positive for gram (+) bacteria indicating methicillin resistant staph aureus infection. Infection was suspected to be the cause of event. However, upon examining the pt's graft, surgeon indicated that the patch appeared normal and the surrounding tissue around the artery was consistent to what would be expected 2 months post surgery. Bleeding was corrected by sealing the anastomosis with add'l sutures. Pt was administered antibiotics and discharged. Pt was seen six weeks later after reintervention. Neck wound cellulitis had resolved and pt was able to return to work.
Patient Sequence No: 1, Text Type: D, B5
[18341098]
Shelhigh (mfr of the vascupatch) became aware of this event as a result of receiving an fda medwatch report. The user facility reported the event only to fda (approx 6 months after incident). After a thorough review of the info supplied by the treating surgeon, it is concluded that the event is related to the surgical procedure and is not device related. The patch graft appeared normal, surrounding tissue was normal, and the post surgical scar tissue was consistent with what is normally expected 2 months post surgery.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247123-2007-00001 |
| MDR Report Key | 840620 |
| Report Source | 00 |
| Date Received | 2007-04-10 |
| Date of Report | 2007-04-09 |
| Date of Event | 2006-08-15 |
| Date Mfgr Received | 2007-04-02 |
| Date Added to Maude | 2007-04-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 650 LIBERTY AVE |
| Manufacturer City | UNION NJ 07083 |
| Manufacturer Country | US |
| Manufacturer Postal | 07083 |
| Manufacturer Phone | 9082068706 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHELHIGH VASCUPATCH |
| Generic Name | PERICARDIAL PATCH GRAFT |
| Product Code | MFX |
| Date Received | 2007-04-10 |
| Model Number | SHP-555-CRT17 |
| Catalog Number | SHP-555-CRT17 |
| Lot Number | NOT AVAILABLE |
| ID Number | * |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 827905 |
| Manufacturer | SHELHIGH |
| Manufacturer Address | * UNION NJ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-04-10 |