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 2017-01-13 for CARBOFLO VASCULAR GRAFTS F7008TWSC manufactured by Bard Peripheral Vascular, Inc..
[64771570]
No medical records and 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 device is not available for return. 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
[64771571]
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
[67558709]
Manufacturing review: the device history record (dhr) for lot this number was reviewed and the lot met all release criteria. The dhr review showed that all process parameters were within specification and that this lot of grafts passed all physical testing requirements. Visual inspection: the sample was not returned; therefore, visual inspection could not be performed. Functional/performance evaluation: the sample was not returned; therefore, functional/performance evaluation could not be performed. Medical records review: medical records were not provided; therefore, a review could not be performed. Image/photo review: images/photos were not provided; therefore, a review could not be performed. Conclusion: the device was not returned. Images and medical records were not provided. The investigation was inconclusive for the alleged graft tears. The definitive root cause could not be determined based upon available information. It was unknown whether patient and/or procedural issues contributed to the event. 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
[67558710]
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 | 2020394-2016-01275 |
| MDR Report Key | 6249844 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2017-01-13 |
| Date of Report | 2016-12-20 |
| Date Mfgr Received | 2017-01-26 |
| Device Manufacturer Date | 2016-01-27 |
| Date Added to Maude | 2017-01-13 |
| 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 | 2017-01-13 |
| Catalog Number | F7008TWSC |
| Lot Number | VTAN0628 |
| 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 W 3RD ST. TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-13 |