MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2016-09-09 for IMPRA VASCULAR GRAFT F7006TWS manufactured by Bard Peripheral Vascular, Inc..
[54406055]
No medical records or medical images have been made available to the manufacturer. As the lot number for the device was provided, a review of the device history records is currently being performed. The device has been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[54406056]
It was reported that during preparation, the beading from the vascular graft was allegedly unraveled. It was further reported that the vascular graft was allegedly torn. There was no reported patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[58760537]
Manufacturing review: a manufacturing review was conducted, the lot met all release criteria. Visual inspection: the sample was bloody. As the reported event was reported to occur during preparation, the blood most likely transferred to the device. The segments returned could not be measured for length due to returned condition. The first segment is the smaller of the two returned segments. The beading is unraveled from the segments and is torn along the beading track. There were no suture holes identified along the length of the returned segment. The second segment consist of what appears to be the remainder of the graft. The beading is unraveled along most of the length of the segment. The graft segment is torn in a spiral manner along the beading track. Remnants of eptfe can be identified on the removed beading. There were no suture holes identified along the length of the returned segment. Functional/performance evaluation: functional testing is not preformed for this type of failure. Medical records review: medical records were not provided; therefore, a review could not be performed. Image/photo review: one digital photo was reviewed. A graft product can be identified within packaging. One end of the graft appears to be torn spirally along the beading track. It can not be determined if the beading is removed from the graft. Based on the image the investigation can be confirmed for torn material. Conclusion: the device was returned for evaluation. One photo was also provided for review. The investigation is confirmed for torn material, as the returned device exhibited spiral tears along the length of the beading track. Labeling review: the current ifu states: precautions: when removing the external spiral support (beading) of the graft, the beading must be removed slowly and at a 90? Angle to the graft. Rapid unwinding and /or removal at less than a 90? Angle may result in graft damage. Do not use surgical blades or sharp, pointed instruments to remove the beading as this may damage the graft wall. If damage occurs, that segment of the graft should not be used. (b)(4). The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[58760538]
It was reported that during preparation, upon removal of the beading from the vascular graft, the graft allegedly tore. There was no patient contact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2016-00863 |
| MDR Report Key | 5941086 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2016-09-09 |
| Date of Report | 2016-08-17 |
| Date of Event | 2016-08-09 |
| Date Mfgr Received | 2016-10-18 |
| Device Manufacturer Date | 2016-01-27 |
| Date Added to Maude | 2016-09-09 |
| 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 | JUDITH LUDWIG |
| Manufacturer Street | 1625 W 3RD ST. |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Street | 1625 W 3RD ST. |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85281 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPRA VASCULAR GRAFT |
| Generic Name | VASCULAR GRAFT |
| Product Code | DYF |
| Date Received | 2016-09-09 |
| Returned To Mfg | 2016-09-06 |
| Catalog Number | F7006TWS |
| Lot Number | VTAN0522 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Address | 1625 W 3RD ST. TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-09 |