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

Model Number	U4150530RX
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
1 of the 3 reported events, 3 lot numbers were provided, and lot history reviews were performed.Of the 3 reported malfunctions, no devices were returned for evaluation.Therefore, the investigation is inconclusive.A root cause has not been determined.The devices were labeled for single use.
Event or Problem Description
This report summarizes three malfunctions.A review of the reported information indicated that model u4150530rx pta balloon dilatation catheter allegedly experienced material rupture.These reports were received from various sources.All three events had no reported patient injury.Age, weight, and gender were not provided for the patients.

• Brand Name: ULTRAVERSE RX 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: 9963335
• Report Number: 2020394-2020-02694
• Device Sequence Number: 13573282
• Product Code: LIT
• UDI-Device Identifier: 00801741058035
• UDI-Public: (01)00801741058035
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/15/2020

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: No Information
• Device Model Number: U4150530RX
• Device Catalogue Number: U4150530RX
• Device Lot Number: CMCV0199, CMCY0298, CMCV0053
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 04/15/2020
• Patient Sequence Number: 1