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

Catalog Number F7006TWS

Device Problem Torn Material (3024)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

No hospital/medical records or medical images have been made available to the manufacturer the lot number for the device has been provided.A review of the device history records is currently being performed.The device has been not returned to the manufacturer for evaluation.The investigation 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 the health care professional was allegedly removing the beads on the graft gently, when the graft tore.Reportedly, the tore section was cut off and the remainder was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the date of event was during the week of 12/24/15; however a specific date was unobtainable.The lot number was provided and the lot device history records were 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 inspection & functional/performance evaluation: the device was not returned; therefore, no visual inspection or functional testing of the device was performed.Medical records review: medical records were not provided for review.Image/photo review: images/photos were not provided for review.Conclusion: the investigation is inconclusive, as a sample was not returned for evaluation.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: do not remove the external spiral support (beading) from any centerflex¿ graft or endflex¿ graft.Attempts to remove the beading may damage the graft wall.If damage occurs, discard the graft.Precautions: when removing the external spiral support (beading) of impra flex¿ grafts, 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.

• Brand Name: IMPRA 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: 5394316
• MDR Text Key: 37431083
• Report Number: 2020394-2016-00131
• Device Sequence Number: 1
• Product Code: DYF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: F7006TWS
• Device Lot Number: VTXH2522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2013
• 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
• Patient Age: 74 YR
• Patient Weight: 77