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

Catalog Number F70T74TSC

Device Problem Torn Material (3024)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2013

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 during the preparation of a vascular graft, it was discovered that the graft was torn.Another vascular graft was prepared and successfully implanted.There is no reported patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Visual inspection: segment 1: the graft was returned used.Approximately 5 rows of beading were removed on one end of the graft.An unknown tie, possibly a suture, was attached to the opposite end of the graft.One partial circumferential tear was observed along the beading track where the beading had been removed.The tear was located approximately 1cm from the edge of the graft there were no signs of stretching at the locations of the tears.The removed beading was still attached to the graft.Segment 2: there was no beading removed from the graft.No tears were identified along the graft.One end of the graft appeared to be slightly compressed.It is unknown how or when the graft was compressed as it was not reported by the user.Segment 3: approximately ½ a row of beading was still present on the graft.Two partial circumferential tears were identified along the first and second beading track.Uneven trimming was identified on one end of the graft.Functional/performance evaluation: an attempt was made to remove the remaining beading at the trimmed end of segment 2.The beading was removed by hand, slowly and at a 90 degree angle to the graft, per the ifu.Approximately 10 rows of beading were removed using this method.There were no holes, rips, or tears noted along the beading track of the newly removed beading.10 more rows of beading were removed.This time, the beading was removed by quickly pulling the beading longitudinally.When removed in this manner, there were still no signs of holes, rips, or tears along the beading track.However, the indentation of the beading track was more pronounced and looked partly gouged in some areas.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 a partial circumferential tears was observed along the beading track of segment 1 and segment 3.Labeling review: the current 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: CARBOFLO VASCULAR 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: 5355217
• MDR Text Key: 35821190
• Report Number: 2020394-2016-00027
• Device Sequence Number: 1
• Product Code: DYF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K004012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2013

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: 09/30/2017
• Device Catalogue Number: F70T74TSC
• Device Lot Number: 20693494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2012
• 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