MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VACCESS PTA DILATATION CATHETER; DQY

Catalog Number VA8088

Device Problems Material Rupture (1546); Material Perforation (2205)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2015

Event Type  Injury  

Event Description

It was reported that during the third inflation in the loop graft, a pta balloon ruptured at 16 atm allegedly causing perforation of the graft leading to extravasation of the contrast solution.The healthcare provider reported a stent graft was used to repair the perforation of the graft.There was no known impact or consequence to patient.

Manufacturer Narrative

No hospital/medical records or medical images have been made available to the manufacturer.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.The sample was returned and evaluated.No anomalies were observed to the device.The patency of the guidewire lumen was tested using a 0.035" in-house guidewire and passed without issue.The catheter inflation hub was then connected to an inflation device and an attempt was made to inflate the balloon with water.Upon inflation, a pinhole rupture on barrel of the balloon.The root cause could not be determined based upon available information.It is unknown if patient and/or procedural issues contributed to the event.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: VACCESS PTA DILATATION CATHETER
• Type of Device: DQY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ
• Manufacturer (Section G): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens TX 75751
• Manufacturer Contact: laura hintz ; 1625 west 3rd st.; tempe, AZ 85281 ; 4808949515
• MDR Report Key: 4947111
• MDR Text Key: 6192494
• Report Number: 2020394-2015-01246
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: VA8088
• Device Lot Number: 93DZ0204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 73