MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-12-02 for BIOGRAFT TUNNELER 323456 manufactured by Boston Scientific Wayne.
[20891969]
The hospital claims that an aorto-bifemoral bypass procedure ended up with an axillo-femoral bypass. During the procedure, the tunneler slipped, but there did not appear to be any "damage" to the pt. However, after closing, the pt's blood pressure dropped remarkably. The pt was then opened up again. It was observed that there had been bleeding that had stopped. The plastic tunneler was found to have sliced through the liver and stomach wall. The pt died later from massive bleeding and kidney failure. Plastic biograft tunneling devices have not been sold by boston scientific/meadox since 1990. That part of the business was sold to biovascular. Boston scientific has been attempting to locate biovascular to inform them of this incident and pt death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000072-2003-00056 |
| MDR Report Key | 499308 |
| Report Source | 05 |
| Date Received | 2003-12-02 |
| Date of Report | 2003-11-04 |
| Date of Event | 2003-07-30 |
| Date Facility Aware | 2003-07-30 |
| Report Date | 2003-11-04 |
| Date Reported to Mfgr | 2003-11-04 |
| Date Mfgr Received | 2003-11-04 |
| Date Added to Maude | 2003-12-08 |
| 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 | 3 |
| Manufacturer Contact | MR MEL POLLINGER |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer Phone | 9737097336 |
| Manufacturer G1 | BOSTON SCIENTIFIC WAYNE |
| Manufacturer Street | 45 BARBOUR POND DR |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07470 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOGRAFT TUNNELER |
| Generic Name | PLASTIC TUNNELER |
| Product Code | MZY |
| Date Received | 2003-12-02 |
| Model Number | 323456 |
| Catalog Number | 323456 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 488075 |
| Manufacturer | BOSTON SCIENTIFIC WAYNE |
| Manufacturer Address | 45 BARBOUR POND DR WAYNE NJ 07470 US |
| Baseline Brand Name | BIOGRAFT TUNNELER |
| Baseline Generic Name | PLASTIC TUNNELER |
| Baseline Model No | 323456 |
| Baseline Catalog No | 323456 |
| Baseline ID | NA |
| Baseline Device Family | BIOGRAFT TUNNELER |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | Y |
| Premarket Approval | P7800 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2003-12-02 |