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

Model Number F7006TWSC

Device Problem Torn Material (3024)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 05/11/2017

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 during a surgical graft implant, the graft tore when the beading was removed.Another surgical graft was used to complete the procedure.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.All process parameters were within specification and this lot of grafts passed all physical testing requirements.Visual/microscopic inspection: as the device was not returned, an inspection could not be performed.Functional/performance evaluation: as the device was not returned, an evaluation could not be performed.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 not returned for evaluation.Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the graft.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 during preparation of a surgical graft, a tear in the graft occurred while removing the beading.A new surgical graft was prepped and implanted without incident.There was no reported patient contact.

• 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: 6652610
• MDR Text Key: 77936726
• Report Number: 2020394-2017-00672
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00801741021596
• UDI-Public: (01)00801741021596(17)210714(10)VTAU0377
• Combination Product (y/n): N
• PMA/PMN Number: K004011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2021
• Device Model Number: F7006TWSC
• Device Catalogue Number: F7006TWSC
• Device Lot Number: VTAU0377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/23/2017
• Initial Date FDA Received: 06/19/2017
• Supplement Dates Manufacturer Received: 07/21/2017
• Supplement Dates FDA Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2016
• 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
• Patient Age: 55 YR