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

Model Number	U357584
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/28/2020
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: PTA DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC. ; 1625 west 3rd st; tempe AZ 85281
• MDR Report Key: 9700571
• Report Number: 9700571
• Device Sequence Number: 3423010
• Product Code: DQY
• UDI-Device Identifier: 00801741093951
• UDI-Public: (01)00801741093951
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/04/2020
• Report Date (Section F): 02/04/2020

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 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/30/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 48