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

Model Number	VA8086
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one vaccess pta dilatation catheter has returned for evaluation.On the visual evaluation of the device, it appeared bloody, no other specific anomalies noted.On the functional evaluation of the device, the guide wire lumen was flushed, and an in-house guide wire was inserted through the catheter without any issue, on further the device was inflated with in-house presto device, water and blood existed out from the balloon.Microscopic observation was performed and noted a compound balloon rupture on the balloon which returned for evaluation.Therefore, the investigation has confirmed for the reported inflation and identified balloon rupture as compound rupture was noted on the balloon and water leaks from the balloon when attempting to inflate.A definitive root cause for the alleged inflation issue and identified balloon rupture could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(expiry date: 02/2024).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly failed to inflate.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: VACCESS PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11861408
• Report Number: 2020394-2021-01080
• Device Sequence Number: 4414016
• Product Code: LIT
• UDI-Device Identifier: 00801741121340
• UDI-Public: (01)00801741121340
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2021

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
• Operator of Device: Health Professional
• Device Model Number: VA8086
• Device Catalogue Number: VA8086
• Device Lot Number: 93NF0164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 50