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

Model Number U4150330

Device Problems Burst Container or Vessel (1074); Material Rupture (1546)

Patient Problems Perforation (2001); Vascular Dissection (3160)

Event Date 06/09/2020

Event Type  Injury  

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 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.

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 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
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10211107
• MDR Text Key: 196907739
• Report Number: 2020394-2020-04137
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741064463
• UDI-Public: (01)00801741064463
• Combination Product (y/n): N
• PMA/PMN Number: K121856
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: U4150330
• Device Catalogue Number: U4150330
• Device Lot Number: CMEN0166
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/09/2020
• Initial Date FDA Received: 06/30/2020
• Supplement Dates Manufacturer Received: 09/30/2020
• Supplement Dates FDA Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 54