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

Catalog Number F7006TWSC

Device Problem Torn Material (3024)

Patient Problem No Patient Involvement (2645)

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 upon opening the package, the vascular graft allegedly tore.There was no reported patient involvement.

Manufacturer Narrative

Manufacturing review: a manufacturing review was conducted, the lot met all release criteria.Visual inspection: the graft was returned.The graft had two blue lines running longitudinally down the graft and had carbon lining, which identified the product as a bard graft.The beading is peeled from one end measuring 5.7cm in length.At this location on the graft a circumferential tear is identified.A small portion of eptfe can be identified on the peeled beading.No other tears, cuts, hole, or anomalies were noted to the length of the returned graft.No suture hole were identified in the length of the returned segment.It appears if both ends of the returned graft were cut.Dimensional evaluation: the graft was measured and found to be within specification.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 confirmed for torn material, as a circumferential tear was observed along the beading track of the returned graft.Per evaluation results, eptfe was found attached to the removed beading.This could indicate improper peeling technique or the beading being adhered too strongly to the base graft.However, the definitive root cause is unknown.Labeling review: the current ifu states: precautions: when removing the external spiral support (beading) of the 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 upon opening the package, the vascular graft allegedly tore.There was no reported patient involvement.

• Brand Name: CARBOFLO VASCULAR GRAFT
• Type of Device: EPTFE VASCULAR 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: 5866721
• MDR Text Key: 51823872
• Report Number: 2020394-2016-00760
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/19/2021
• Device Catalogue Number: F7006TWSC
• Device Lot Number: VTAN0546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2016
• 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