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

Model Number	U415034RX
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
Of the reported 2 events, both lot numbers for the devices were provided, a manufacturing review will be performed.One sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.One sample was returned to the manufacturer for inspection/evaluation and material rupture was confirmed for the device.Based upon the available information, the definitive root cause for this event is unknown.The device was labeled for single use.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model u415034rx pta balloon dilatation catheter allegedly experienced material rupture.These reports were received from various sources.Both events did involve patients with no reported patient injury.One patient is (b)(6) old, (b)(6) , and female; however, the second patients¿ weight, gender and age were not reported.

• 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: 9963690
• Report Number: 2020394-2020-02715
• Device Sequence Number: 19469480
• Product Code: LIT
• UDI-Device Identifier: 00801741056802
• UDI-Public: (01)00801741056802
• 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: U415034RX
• Device Catalogue Number: U415034RX
• Device Lot Number: CMCR0187, CMDS0042
• 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