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

Catalog Number F8006TWSC

Device Problem Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Date 04/10/2014

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 serial 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.

Event Description

It was reported that during preparation the surgical graft tore, a new surgical graft was implanted.There is no reported patient contact.

Manufacturer Narrative

Manufacturing review: a manufacturing review was conducted.The lot met all release criteria.Visual inspection(s): segment 1: segment 1 appeared clean.The graft segment had two blue lines running longitudinally down the graft and had carbon lining, which identified the product as a bard graft.The segment measured approximately 78.8cm long.The beading was unraveled at one end of the segment for 12.4cm.One partial circumferential tear was observed along the beading track where the beading had been removed.The tear was located approximately 1.4cm from the edge of the segment.There were no signs of stretching at the locations of the tears.The removed beading was still attached to the segment of graft.Both ends of the segment have uneven cuts.Segment 2: segment 2 appeared clean.The graft segment had two blue lines running longitudinally down the graft and had carbon lining, which identified the product as a bard graft.The segment measured approximately 2.7cm long.The beading was unraveled at one end of the segment for 8.8cm.Two partial circumferential tears were observed along the beading track where the beading had been removed.The tears were located approximately 0.9cm and 1.2cm from the edge of the segment.There were no signs of stretching at the locations of the tears.The removed beading was still attached to the graft.End of segment with unraveled beading has even cut, other end of segment has uneven cut.Dimensional evaluation: the length of the graft measured approximately 81.5cm.This measurement was within specification.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 confirmed for torn material, as a partial circumferential tears were observed along the beading track of segment 1 and segment 2.The root cause could not be determined based upon available information.It is unknown whether procedural factors contributed to the event.Labeling review: the current ifu (instructions for use) states: warnings: impra® 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 grafts 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.Avoid repeated or excessive clamping at the same location on the graft.If clamping is necessary, use only atraumatic or appropriate vascular smooth jawed clamps to avoid damage to the graft wall.

• Brand Name: CARBOFLO VASCULAR GRAFT
• Type of Device: EPTFE 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: 5356898
• MDR Text Key: 35996178
• Report Number: 2020394-2016-00072
• Device Sequence Number: 1
• Product Code: DYF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K004012
• 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: 04/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: F8006TWSC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2013
• 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