MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-08-10 for CARBOFLO VASCULAR GRAFT F7006TWSC manufactured by Bard Peripheral Vascular, Inc..
[51823872]
No medical records or no medical images have been made available to the manufacturer. The device has been returned to the manufacturer for evaluation. As the lot number for the device was provided, a review of the device history records is currently being performed. 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
[51823873]
It was reported that upon opening the package, the vascular graft allegedly tore. There was no reported patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[57592715]
Manufacturing review: a manufacturing review was conducted, the lot met all release criteria. Visual inspection: the graft was returned. The graft had two blue lines running longitudinally down the graft and had carbon lining, which identified the product as a bard graft. The beading is peeled from one end measuring 5. 7cm in length. At this location on the graft a circumferential tear is identified. A small portion of eptfe can be identified on the peeled beading. No other tears, cuts, hole, or anomalies were noted to the length of the returned graft. No suture hole were identified in the length of the returned segment. It appears if both ends of the returned graft were cut. Dimensional evaluation: the graft was measured and found to be within specification. Functional/performance evaluation: no functional testing was performed. Medical records review: as medical records were not provided, a review could not be performed. Image/photo review: no medical images have been made available to the manufacturer. Conclusion: the investigation is confirmed for torn material, as a circumferential tear was observed along the beading track of the returned graft. Per evaluation results, eptfe was found attached to the removed beading. This could indicate improper peeling technique or the beading being adhered too strongly to the base graft. However, the definitive root cause is unknown. 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. 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
[57592716]
It was reported that upon opening the package, the vascular graft allegedly tore. There was no reported patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2016-00760 |
| MDR Report Key | 5866721 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-08-10 |
| Date of Report | 2016-07-15 |
| Date Mfgr Received | 2016-09-16 |
| Device Manufacturer Date | 2016-01-27 |
| Date Added to Maude | 2016-08-10 |
| 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 | CARBOFLO VASCULAR GRAFT |
| Generic Name | EPTFE VASCULAR GRAFT |
| Product Code | DYF |
| Date Received | 2016-08-10 |
| Returned To Mfg | 2016-07-28 |
| Catalog Number | F7006TWSC |
| Lot Number | VTAN0546 |
| 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 | 2016-08-10 |