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

Catalog Number DFX7006SC

Device Problem Torn Material (3024)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/26/2013

Event Type  malfunction  

Manufacturer Narrative

A further clinical review of the event details was completed and a change in the mdr reportability was identified.No medical records or no 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 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 Description

It was reported that the vascular graft tore during the implantation procedure.The graft was revised and the procedure was successfully completed with the same graft.There was no reported injury to the patient.

Manufacturer Narrative

Manufacturing review: a manufacturing review was conducted.The lot met all release criteria.Visual inspection: the graft was returned in 3 separate segments.Blue lines and carbon lining were identified on all segments which confirmed that this is a bard graft.Segment one measured approximately 22cm in length.Both sides of the segment appeared trimmed and the tears did not appear to be jagged.The right side of the segment had 39cm of beading removed.The tears on the right side of the segment measured approximately 6cm in length.The left side of the segment had 22cm of beading removed.The tears on the left side measured approximately 5cm in length.No evidence of peeling was noted.No evidence of sutures were identified.Segment two measured approximately 2.5cm in length.The beading was removed.No evidence of sutures were identified.No tears/or rips were identified along the length of segment 2.The graft segment appeared trimmed with clean cuts.It appeared to be remnant material from the procedure.Segment three measured approximately 3cm in length.No beading was present.No evidence of sutures was identified.The segment appeared to be a cutout from the graft as the edges were smooth.Functional/performance evaluation: no functional testing was performed.Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the investigation is inconclusive for torn material as the graft was not returned in its entirety.No evidence of suturing was found.Possible tears were found on segment one, however it is unknown whether the tears were the result of trimming.It is unknown if patient and/or procedural issues contributed to the reported event.Based on the available information, the definitive root cause is unknown.Labeling review: the current distaflo mini-cuff bypass graft instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.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.

• Brand Name: DISTAFLO MINI-CUFF BYPASS GRAFT
• Type of Device: VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5354918
• MDR Text Key: 35818178
• Report Number: 2020394-2016-00052
• Device Sequence Number: 1
• Product Code: DYF
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/29/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: DFX7006SC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2012
• 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
• Patient Age: 90 YR