MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CARBOFLO VASCULAR GRAFTS; EPTFE VASCULAR GRAFT

Catalog Number	F5006TWSC
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: CARBOFLO VASCULAR GRAFTS
• Common Device Name: EPTFE VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6173561
• Report Number: 2020394-2016-01173
• Device Sequence Number: 378197
• Product Code: DYF
• UDI-Device Identifier: 00801741021558
• UDI-Public: (01)00801741021558(17)201208(10)VTZL0360
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K004012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/08/2020
• Device Catalogue Number: F5006TWSC
• Device Lot Number: VTZL0360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/14/2016
• Supplement Report FDA Received Date: 02/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1