MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2016-09-19 for IMPRA VASCULAR GRAFT F7008TWS manufactured by Bard Peripheral Vascular, Inc..
[55055058]
No medical records or no 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
[55055059]
It was reported that during an intraoperative procedure, upon removal of the beading from the vascular graft, the graft allegedly tore. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[59164813]
Manufacturing review: the device history records have been reviewed with special attention to the subassemblies, material review reports, raw material testing, manufacturing process, and quality control inspection. This lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. This is the only complaint that has been reported for this corporate lot number to date. Visual inspection: the graft was returned. Blue lines and carbon lining were identified on the segment which confirmed that this was a bard graft. The whole length of the graft appeared to be returned. On one end of the returned graft had the beading removed for approximately 10. 0cm of graft length. No tears were noted in this portion of the graft. The other end of the graft also had the beading removed. The graft appeared spirally torn along the beading track of the graft length. There were no suture marks or holes noted along the entire length of the returned graft. Functional/performance evaluation: no functional testing was performed due to the condition of the returned sample (i. E. Torn graft material). Medical records review: medical records were not provided; therefore, a review could not be performed. Photo review: one digital photo was returned and reviewed. One graft was packaged, identified as a bard graft. In the photo blue lines could be identified running along the length of the graft. The graft appeared to be spirally torn along the beading track. Based on the image the investigation could be confirmed for torn material. Conclusion: the investigation was confirmed for torn material, as the returned graft was spirally torn along the beading track. The root cause could not be determined based upon available information. It was unknown whether procedural factors contributed to the event. Labeling review: the current ifu (instructions for use) states: warnings: do not remove the external spiral support (beading) from any centerflex? Graft or endflex? Graft. Attempts to remove the beading may damage the graft wall. If damage occurs, discard the graft precautions: when removing the external spiral support (beading) of impra flex? Grafts, 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. 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
[59164814]
It was reported that during an intraoperative procedure, upon removal of the beading from the vascular graft, the graft allegedly tore. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2016-00881 |
| MDR Report Key | 5960367 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2016-09-19 |
| Date of Report | 2016-08-24 |
| Date Mfgr Received | 2016-11-01 |
| Device Manufacturer Date | 2016-01-13 |
| Date Added to Maude | 2016-09-19 |
| 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 | 2016-09-19 |
| Returned To Mfg | 2016-09-06 |
| Catalog Number | F7008TWS |
| Lot Number | VTAN0270 |
| 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 | 2016-09-19 |