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 2016-10-26 for CARBOFLO EPTFE VASCULAR GRAFT F8006TWSC manufactured by Bard Peripheral Vascular, Inc..
[58456044]
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
[58456045]
It was reported that after implantation of the vascular graft an alleged split was identified approximately 3/4 of the way down from the suture site; therefore, the torn section of the graft was cut and removed. It was further reported that the remainder of the graft was re sutured, and the procedure was completed. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
[60912030]
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 & functional/performance evaluation: the device was not returned; therefore, no visual inspection or functional testing of the device was performed. Medical records review: medical records were not provided for review. Image/photo review: images/photos were not provided for review. Conclusion: the investigation was inconclusive for torn material, as the sample was not returned for evaluation. 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 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; (conclusion); 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
[60912031]
It was reported that after implantation of the vascular graft an alleged split was identified approximately? Of the way down from the suture site; therefore, the torn section of the graft was cut and removed. It was further reported that the remainder of the graft was re sutured, and the procedure was completed. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2016-01006 |
| MDR Report Key | 6059392 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2016-10-26 |
| Date of Report | 2016-09-30 |
| Date of Event | 2016-09-28 |
| Date Mfgr Received | 2016-11-01 |
| Device Manufacturer Date | 2015-11-17 |
| Date Added to Maude | 2016-10-26 |
| 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 EPTFE VASCULAR GRAFT |
| Generic Name | EPTFE VASCULAR GRAFT |
| Product Code | DYF |
| Date Received | 2016-10-26 |
| Catalog Number | F8006TWSC |
| Lot Number | VTZK0436 |
| 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 | 2016-10-26 |