MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-12-14 for CARBOFLO VASCULAR GRAFTS F5006TWSC manufactured by Bard Peripheral Vascular, Inc..
[62382787]
No device, no medical records, or no medical images were provided to the manufacturer. The lot number for the device was provided. The device history records are currently under review. 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
[62382788]
It was reported that during an intraoperative procedure, an alleged tear in the vascular graft was identified upon removal of the beading. The health care provider removed the torn segment and completed the procedure with the vascular graft. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
[66911400]
Manufacturing review: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing. 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 event reported to date for this lot number and failure mode. Visual inspection: a segment of the graft was returned with the product packaging and label. The graft segment had two blue lines running longitudinally and had carbon lining, which identified the product as a bard graft. The segment measured 4. 1cm in length at its longest point. The beading was missing along entire returned length. It appeared that one end of the returned graft was cut. The other end appeared to be torn. There was a tear along the beading track of the returned segment. Medical records review: medical records were not provided for review. Image/photo review: images/photos were not provided for review. Conclusion: the investigation was confirmed for torn material, as the returned segment had a tear along the beading track. It was unknown if procedural issues contributed to the reported event. Based on the available information, the definitive root cause was 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
[66911401]
It was reported that during an intraoperative procedure, an alleged tear in the vascular graft was identified upon removal of the beading. The health care provider removed the torn segment and completed the procedure with the vascular graft. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2016-01173 |
| MDR Report Key | 6173561 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-12-14 |
| Date of Report | 2016-11-18 |
| Date of Event | 2016-11-17 |
| Date Mfgr Received | 2017-01-27 |
| Device Manufacturer Date | 2015-12-13 |
| Date Added to Maude | 2016-12-14 |
| 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 GRAFTS |
| Generic Name | EPTFE VASCULAR GRAFT |
| Product Code | DYF |
| Date Received | 2016-12-14 |
| Returned To Mfg | 2016-12-13 |
| Catalog Number | F5006TWSC |
| Lot Number | VTZL0360 |
| 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 | 2016-12-14 |