MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-11-04 for GORE-TEX * manufactured by *.
[965504]
Pt had placed in his left arm, a brachial cephalic fistula in 2001 for the purpose of dialysis. The fistula did well until late 2007 when there were frequent bleeding episodes post dialysis. One area of the upper arm appeared to enlarge, in the form of an egg. There appeared to be an area in which the skin opened, and in 2008, the fistula broke through and pt bled to death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5008840 |
| MDR Report Key | 1220583 |
| Date Received | 2008-11-04 |
| Date of Report | 2008-10-24 |
| Date of Event | 2008-03-09 |
| Date Added to Maude | 2008-11-07 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GORE-TEX |
| Generic Name | AV FISTULA - BRACHIAL - CEPHALIC |
| Product Code | FIQ |
| Date Received | 2008-11-04 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1268618 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2008-11-04 |