MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DISTAFLO MINI BYPASS GRAFT; EPTFE VASCULAR GRAFT

Catalog Number	DFX9006SC
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that during a bypass graft implantation from the right femoral artery to the right anterior tibial artery, the bypass graft allegedly tore while positioning it distally.Reportedly, the graft was removed and the health care provider switched to another site and successfully implanted another bypass graft.There was no reported patient injury.
Additional Manufacturer Narrative
The device history records have been reviewed with special attention to the subassemblies, manufacturing process, and quality control inspection.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Visual inspection: the sample was not returned; therefore, a visual inspection could not be performed.Functional/performance evaluation: the sample was not returned; therefore, functional/performance evaluation could not be performed.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 device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation was inconclusive for the alleged tear in the graft.Based upon the available information, the definitive root cause was unknown.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.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 bypass graft implantation from the right femoral artery to the right anterior tibial artery, the bypass graft allegedly tore while positioning it distally.Reportedly, the graft was removed and the health care provider switched to another site and successfully implanted another bypass graft.There was no reported patient injury.

• Brand Name: DISTAFLO MINI BYPASS GRAFT
• Common Device Name: EPTFE VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6415669
• Report Number: 2020394-2017-00211
• Device Sequence Number: 30763
• Product Code: DYF
• UDI-Device Identifier: 00801741023682
• UDI-Public: (01)00801741023682(17)210912(10)VTAW0355
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K983769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2017

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: 09/12/2021
• Device Catalogue Number: DFX9006SC
• Device Lot Number: VTAW0355
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/21/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2017
• Supplement Report FDA Received Date: 04/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 60