MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-01-04 for GORETEX LOOP FISTULA UNK manufactured by W.l. Gore & Associates Inc. Medical Products Div..
[40043]
Pt had a left av fistula placed 4/16/93, revised twice, declotted with urokinase infusion 4/95. Recently noted that pt had a poor functioning graft. Pt had surgery 7/19/96, an exploration of a malfunctioning left forearm loop fistula with placement of a new tapered fistula, end of 4mm graft to side of brachial artery, end of 7mm graft to the end of the previous fistula. Intra-op finding demonstrates that there is an abnormal connection between the loop of the fistula and a vein.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 66261 |
| MDR Report Key | 66261 |
| Date Received | 1997-01-04 |
| Date of Report | 1996-07-25 |
| Date of Event | 1996-07-19 |
| Date Facility Aware | 1996-07-19 |
| Report Date | 1996-07-25 |
| Date Reported to Mfgr | 1996-07-26 |
| Date Added to Maude | 1997-02-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GORETEX LOOP FISTULA |
| Generic Name | GORETEX LOOP FISTULA |
| Product Code | MCI |
| Date Received | 1997-01-04 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 66339 |
| Manufacturer | W.L. GORE & ASSOCIATES INC. MEDICAL PRODUCTS DIV. |
| Manufacturer Address | 3300 SPARROW PO BOX 3200 FLAGSTAFF AZ 860033200 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1997-01-04 |