MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA CATHETER PTA BALLOON DILATATION CATHETER

Model Number U357586

Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

Patient Problem Injury (2348)

Event Date 04/14/2020

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a lot history review is currently being performed. The device has been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. Medical device - expiry date: 05/2022.

Event Description

It was reported that during an angioplasty procedure in the brachial artery, the pta balloon allegedly ruptured. It was further reported that the balloon tore in half after the delivery system became stuck on the guidewire. Reportedly, medical intervention was required to remove the detached segment. The detached segment was successfully removed from the patient. Patient is reportedly stable.

• Brand Name: ULTRAVERSE 035 PTA CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10047828
• MDR Text Key: 190650491
• Report Number: 2020394-2020-03389
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: U357586
• Device Catalogue Number: U357586
• Device Lot Number: CMDT0608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/12/2020 Patient Sequence Number: 1