MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	U4150330
Date of Event	06/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.Expiry date (12/2022).
Event or Problem Description
It was reported that during an angioplasty procedure through tibial artery, the pta balloon allegedly had a pinhole ruptured at 4 atm in the posterior tibial (pt) artery.It was further reported that the treatment plan changed to at/pedal loop.The procedure was completed using another device.The patient status is unknown.
Additional Manufacturer Narrative
Manufacturing review: a lot history review was conducted and it was determined that a device history record review was not required.Investigation summary: the investigation is inconclusive for the reported balloon rupture, as the device was not returned for evaluation.The definitive root cause for the reported balloon rupture could not be determined based upon available 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: 12/2022).
Event or Problem Description
It was reported that during an angioplasty procedure through tibial artery, the pta balloon allegedly had a pinhole ruptured at 4 atm in the posterior tibial (pt) artery.It was further reported that the treatment plan changed to at/pedal loop.The procedure was completed using another device.The patient status is unknown.

• Brand Name: ULTRAVERSE 014 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: 10211107
• Report Number: 2020394-2020-04137
• Device Sequence Number: 2133913
• Product Code: LIT
• UDI-Device Identifier: 00801741064463
• UDI-Public: (01)00801741064463
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K121856
• 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,Followup
• Report Date (Section B): 10/15/2020

1 Device was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: U4150330
• Device Catalogue Number: U4150330
• Device Lot Number: CMEN0166
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 10/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No