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

Model Number	F7007TWSC
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No hospital/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.
Event or Problem Description
It was reported that during a surgical graft implant, the graft tore when the beading was removed.Another surgical graft was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the lot number has been provided and the lot device history records have been reviewed.The lot met all release criteria.All process parameters were within specification and that this lot of grafts passed all physical testing requirements.Visual/microscopic inspection: as the device was not returned, an inspection could not be performed.Functional/performance evaluation: as the device was not returned, an evaluation could not be performed.Medical records review: no medical records have been made available to the manufacturer.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for the alleged tear as no objective evidence has been provided to confirm any alleged deficiency with the device.The definitive root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.Labeling review: the current instructions for use (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.
Event or Problem Description
It was reported that during a surgical graft implant, the graft tore when the beading was removed.Another surgical graft was used to complete the procedure.There was no reported patient injury.

• Brand Name: IMPRA CARBOFLO EPTFE VASCULAR GRAFT
• Common Device Name: EPTFE VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6652554
• Report Number: 2020394-2017-00665
• Device Sequence Number: 13774460
• Product Code: DSY
• UDI-Device Identifier: 00801741021602
• UDI-Public: (01)00801741021602(17)210322(10)VTAQ0645
• Combination Product (Y/N): N
• PMA/510(K) Number: K004011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2017

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: 03/22/2021
• Device Model Number: F7007TWSC
• Device Catalogue Number: F7007TWSC
• Device Lot Number: VTAQ0645
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2017
• Supplement Date Received by Manufacturer: 07/20/2017
• Initial Report FDA Received Date: 06/19/2017
• Supplement Report FDA Received Date: 07/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR