MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-12-14 for PTFE VASCULAR GRAFTS SOFT >=6MM 481036 manufactured by Boston Scientific - Wayne.
[18241067]
Original info as rec'd: (hyperpiesia male pt. This device was implanted as a graft shunt in 2007 by same physician. Pta was performed on several days before the procedure, but the physician didn't touch the shunt area. The procedure was held for fixing the graft to stop blood leakage. The physician was attempted to exteriorize the graft venous side by incision in the skin. When cut out the skin, blood was overflowing. The cut out position was changed to more venous side. The skin was cut out. The physician got the clamp under the graft, and he lifted the graft just a little bit. The graft was broken (separated). While a nurse was holding the graft venous side, the physician tied up the aterial site. The blood flow was stopped. The physician visually checked the graft, and he noticed that a sizable hole on the graft. In the region of the hole area was not for the puncture area for usual artificial dialysis. The physician's comment; he had never hurt the graft in this procedure or previous procedures. The graft has been implanted for nearly two months. But it seemed to be deteriorated. ) two months later, we rec'd the following updated info: the physician claims that the pt had symptoms of vein hyperpiesia after the graft was implanted on original date. The graft was implanted as an arterial/venous shunt in preparation for a dialysis procedure. Percutaneous transverse angioplasty (pta) was performed for a lesion located on the superior vena cava several days before the dialysis procedure without touching the shunt area. On the following month, prior to starting the dialysis procedure the graft, still under the skin, was observed to be leaking blood. The physician cut the skin to exteriorize the graft's venous side. There was excessive bleeding from the wound area when the skin was cut. The graft was then clamped. As the graft was lifted, it was observed to have a tear at its brachial venous area. The physician then tied the arterial side and stopped the blood flow (approx 200ml to 300ml of blood reported to have been lost through the graft). Upon checking the graft, the physician also noticed a hole that was not located in the region of the dialysis puncture, but proximal to the tear at the brachial venous area. The procedure was completed with this device. The physician reported that there was no serious injury to the pt and that the pt is making satisfactory progress.
Patient Sequence No: 1, Text Type: D, B5
[18341206]
Since no product is available to be returned for our eval, the complaint cannot be confirmed or denied. Following our investigation, which included a physician's report and a device history review, we have concluded that due to a lack of sufficient info, a probable root cause for this incident cannot be determined at this time. A need for corrective action regarding this type of complaint is being addressed at this time. We will continue to monitor and trend this type of complaint in order to ensure that there is no compromise with product quality. Method: the device history records for the batch were reviewed. Results: all mfg and qa testing was carried out in accordance with our standard procedures. The device history record for this batch shows that the product met its specs at the time of release to distribution - there are no similar incidents against this batch.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000072-2007-00047 |
| MDR Report Key | 964528 |
| Report Source | 05 |
| Date Received | 2007-12-14 |
| Date of Report | 2007-12-04 |
| Date of Event | 2007-11-29 |
| Date Facility Aware | 2007-11-29 |
| Report Date | 2007-12-04 |
| Date Reported to Mfgr | 2007-12-04 |
| Date Mfgr Received | 2007-12-04 |
| Device Manufacturer Date | 2007-07-01 |
| Date Added to Maude | 2008-03-28 |
| 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 DR. |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer Phone | 9737097336 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PTFE VASCULAR GRAFTS SOFT >=6MM |
| Generic Name | VASCULAR GRAFT |
| Product Code | FIQ |
| Date Received | 2007-12-14 |
| Model Number | 481036 |
| Catalog Number | 481036 |
| Lot Number | 9737607 |
| ID Number | NA |
| Device Expiration Date | 2010-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 980565 |
| Manufacturer | BOSTON SCIENTIFIC - WAYNE |
| Manufacturer Address | WAYNE NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-12-14 |