MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-27 for IMPRA VASCULAR GRAFT F7006TWS manufactured by Bard Peripheral Vascular, Inc..
[37431083]
No hospital/medical records or medical images have been made available to the manufacturer the lot number for the device has been provided. A review of the device history records is currently being performed. The device has been not returned to the manufacturer for evaluation. The investigation 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
[37431084]
It was reported that the health care professional was allegedly removing the beads on the graft gently, when the graft tore. Reportedly, the tore section was cut off and the remainder was used to complete the procedure. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
[39786254]
Manufacturing review: the date of event was during the week of 12/24/15; however a specific date was unobtainable. The lot number was provided and the lot device history records were reviewed. The 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 reported for this lot number and issue to date. Visual inspection & functional/performance evaluation: the device was not returned; therefore, no visual inspection or functional testing of the device was performed. Medical records review: medical records were not provided for review. Image/photo review: images/photos were not provided for review. Conclusion: the investigation is inconclusive, as a sample was not returned for evaluation. The root cause could not be determined based upon available information. It is 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
| Report Number | 2020394-2016-00131 |
| MDR Report Key | 5394316 |
| Date Received | 2016-01-27 |
| Date of Report | 2016-01-04 |
| Date Mfgr Received | 2016-02-26 |
| Device Manufacturer Date | 2013-09-04 |
| Date Added to Maude | 2016-01-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 WEST 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 WEST 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 | 2016-01-27 |
| Catalog Number | F7006TWS |
| Lot Number | VTXH2522 |
| Device Expiration Date | 2018-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Address | 1625 WEST 3RD ST. TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-27 |