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

Catalog Number F8008TWSC

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2017

Event Type  malfunction  

Manufacturer Narrative

No hospital/medical records or 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 not 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 after suturing the first vessel during a cross over bypass procedure, the physician was removing the stabilizing spiral and noted tears/holes in the vascular graft.The graft was removed and another graft was successfully prepped and sutured in place.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the lot number has been provided and the lot device history records have been reviewed.The 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 reported for this lot number and issue to date.Visual/microscopic inspection: the first segment of graft measured 1.6 cm in length.No beading was on this returned segment of graft.Both ends of segment appear to be cut.There were no tears, rips, or suture holes noted in the returned segment.The second segment of the graft measured 42.6 cm in length.Beading was present on the entire length of the segment.Both ends of the segment appear to be cut.There were no tears, rips, or suture holes noted in the returned segment.Dimensional evaluation: the total length of the returned segments measured 44.2 cm.The length specification is 80 cm +5/-0 cm.This measurement was not within specification.35.8 cm of graft was not returned for evaluation.Medical records review: no medical records have been made available to the manufacturer.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the device was returned for evaluation.The returned device was received in two separate segments.The first returned segment had no beading appeared to have been used.The second segment had beading along the entire length of the returned segment and appeared not to have been used.There were no tears noted in either of the returned segments.It is unknown if the first segment tore from the returned second segment.The entirety of the graft was not returned for evaluation.Therefore, the investigation in inconclusive for the alleged torn material.The definitive root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.Labeling review: the current instructions for use (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 after suturing the first vessel during a cross over bypass procedure, the physician was removing the stabilizing spiral and noted tears/holes in the vascular graft.The graft was removed and another graft was successfully prepped and sutured in place.There was no reported patient injury.

• Brand Name: IMPRA CARBOFLO EPTFE 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: 6598719
• MDR Text Key: 76241728
• Report Number: 2020394-2017-00531
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00801741021640
• UDI-Public: (01)00801741021640(17)210302(10)VTAQ0083
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K004011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2021
• Device Catalogue Number: F8008TWSC
• Device Lot Number: VTAQ0083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2016
• 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