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 2016-12-19 for DISTAFLO MINI BYPASS GRAFT DFX8006SC manufactured by Bard Peripheral Vascular, Inc..
[62789770]
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 return of the device is pending. 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
[62789771]
It was reported that during an intraoperative procedure, upon removal of the beading from the vascular graft, the graft allegedly tore in the femoral artery; therefore, the graft was shortened and the anastomosis was completed with the remainder of the graft. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
[68490867]
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. Visual inspection: the one segment had two blue lines running down the length of the graft and carbon inner lining, thus identifying it as a bard product. Trace amounts of fluid were visible along the body of the graft segment. The segment measured approximately 1. 9cm in length. No suture holes were identified. The beading was peeled off throughout the entire length of the segment. The segment was torn spirally in two location along the beading track. One end of the segment appears torn while the other end appears to be cut. Dimensional evaluation: segment of the graft measured approximately 1. 9 cm in total length. This measurement was below specification. Therefore, the entirety of the graft was not returned for evaluation. 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 investigation was confirmed for torn material, as partial circumferential tears were observed along the beading track of the returned segment. 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. Further investigation is being performed to determined the bead tear issue across eptfe vascular graft products. Labeling review: the current ifu states: precautions: when removing the external spiral support (beading) of the distaflo? 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
[68490868]
It was reported that during an intraoperative procedure, upon removal of the beading from the vascular graft, the graft allegedly tore in the femoral artery; therefore, the graft was shortened and the anastomosis was completed with the remainder of the graft. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2016-01181 |
| MDR Report Key | 6187549 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-12-19 |
| Date of Report | 2016-11-25 |
| Date of Event | 2016-11-24 |
| Date Mfgr Received | 2017-02-08 |
| Device Manufacturer Date | 2015-12-04 |
| Date Added to Maude | 2016-12-19 |
| 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 | DISTAFLO MINI BYPASS GRAFT |
| Generic Name | EPTFE VASCULAR GRAFT |
| Product Code | DYF |
| Date Received | 2016-12-19 |
| Returned To Mfg | 2016-12-21 |
| Catalog Number | DFX8006SC |
| Lot Number | VTZL0099 |
| 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 | 2016-12-19 |