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

Catalog Number DFX8006SC

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2016

Event Type  malfunction  

Manufacturer Narrative

No medical records or no medical images have been made available to the manufacturer.The device has been returned to the manufacturer for evaluation.As the lot number for the device was provided, a review of the device history records is currently being performed.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 Description

It was reported that the vascular bypass graft allegedly tore during implantation in the femoral popliteal artery.Reportedly, another graft was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

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 device was returned in two segments.The two segments had two blue lines running down the length of the graft and carbon inner lining, thus identifying them as bard products.Trace amounts of fluid were visible along the body of the graft segments that were returned.The first segment measured approximately 1.1cm in length.No suture holes were identified.The beading was peeled off throughout most of the entire length of the segment.The segment was torn spirally in two locations along the beading track.The second segment measured approximately 1.4cm in length.No suture hold, tears, or rips were identified throughout the length of the segment.The beading was intact throughout the entire length of the segment.Dimensional evaluation: segments of the graft measured approximately 2.5cm in total length.The length specification is 80cm +5/-0cm.This measurement was below specification.Therefore, the entirety of the 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 is confirmed for torn material, as partial circumferential tears were observed along the beading track of the returned segment.It is unknown if procedural issues contributed to the reported event.Based on the available information, the definitive root cause is unknown.Labeling review: the current ifu states: precautions: when removing the external spiral support (beading) of the distaflo® 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 Description

It was reported that the vascular bypass graft allegedly tore during implantation in the femoral popliteal artery.Reportedly, another graft was used to complete the procedure.There was no reported patient injury.

• Brand Name: DISTAFLO MINI-CUFF EPTFE VASCULAR BYPASS GRAFT
• Type of Device: EPTFE VASCULAR BYPASS GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5960366
• MDR Text Key: 55054918
• Report Number: 2020394-2016-00879
• Device Sequence Number: 1
• Product Code: DYF
• UDI-Device Identifier: 00801741023675
• UDI-Public: (01)00801741023675(17)201205(10)VTZL0267
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K983769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2020
• Device Catalogue Number: DFX8006SC
• Device Lot Number: VTZL0267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1