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

Model Number U357584

Device Problem Material Rupture (1546)

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

Event Date 01/28/2020

Event Type  malfunction  

Event Description

Balloon ruptured upon inflation and was retrieved during percutaneous angioplasty of left cephalic outflow vein in the upper arm.

• Brand Name: ULTRAVERSE 035 PTA DILATATION CATHETER, OTW
• Type of Device: PTA DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC. ; 1625 west 3rd st; tempe AZ 85281
• MDR Report Key: 9700571
• MDR Text Key: 179244253
• Report Number: 9700571
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741093951
• UDI-Public: (01)00801741093951
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: U357584
• Device Catalogue Number: U357584
• Device Lot Number: CMDU0023
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/04/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/30/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 48