MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2016-10-28 for CARBOFLO VASCULAR GRAFT F5006SC manufactured by Bard Peripheral Vascular, Inc..
[58815876]
No medical records or medical images have been made available to the manufacturer. As the lot number for the device was provided, a review of the device history records is currently being performed. The device has not been returned to the manufacturer for evaluation. 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
[58815877]
It was reported that the vascular graft material was allegedly tearing during the procedure. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
[63933883]
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. This is the only complaint that has been reported for this corporate lot number to date. Visual inspection: the graft had some fluid located on the returned segment. The graft segment had two blue lines running longitudinally down the graft segment and had carbon lining, which identified the product as a bard graft. The segment measure 4. 0 cm in length. The beading was intact and present along the returned segment. It appears that both ends of the returned graft were cut. No holes, tears, or sutures were identified on the returned segment of graft. Dimensional evaluation: the graft measured approximately 4. 0 cm long. This measurement was not within specification. 46 cm of 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 inconclusive, as the returned graft segment had no holes, tears, or splits. However, the entirety of the graft was not returned for evaluation. The root cause could not be determined based upon available information. It was unknown whether procedural factors contributed to the event. Labeling review: the current instruction for use (ifu) states: eptfe grafts do not stretch (are non-elastic) in the longitudinal direction. The correct graft length for each procedure must be determined by considering the patient's body weight, posture, and the range of motions across the anatomical area of graft implantation. Failure to cut the graft to an appropriate length may result in anastomotic or graft disruption, leading to excessive bleeding, and loss of limb or limb function, and/or death. Aggressive and/or excessive graft manipulation when tunneling, or placement within a too tight or too small tunnel, may lead to separation of the spiral beading and/or graft breakage. When suturing, avoid excessive tension on the suture line, inappropriate suture spacing and bites, and gaps between the graft and host vessel. Failure to follow correct suturing techniques may result in suture hole elongation, suture pull-out, anastomotic bleeding and/or disruption. Additional mfr narrative: date received by mfr. Device available for evaluation? , device evaluated by mfr? , (b)(4). 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
[63933884]
It was reported that the vascular graft material was allegedly tearing during the procedure. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2016-01012 |
| MDR Report Key | 6063561 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2016-10-28 |
| Date of Report | 2016-10-03 |
| Date of Event | 2016-09-28 |
| Date Mfgr Received | 2016-12-09 |
| Device Manufacturer Date | 2015-07-06 |
| Date Added to Maude | 2016-10-28 |
| 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 | 2016-10-28 |
| Returned To Mfg | 2016-11-07 |
| Catalog Number | F5006SC |
| Lot Number | VTZF0680 |
| 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 | 2016-10-28 |