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

Model Number	U4150415RX
Medical Device Problem Codes	Failure to Advance (2524); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the malfunction was not provided; therefore, a lot history will not be performed.The device was returned, and was confirmed for material deformation and device-device incompatibility; however, inconclusive for failure to advance.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 one malfunction.A review of the reported information indicated that model u4150415rx pta balloon dilatation catheter allegedly experienced failure to advance and material deformation.This information was received from one source.The event involved a patient with no known impact to the patient.The patient age, weight, and gender were not provided.

• 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: 9592010
• Report Number: 2020394-2020-00309
• Device Sequence Number: 10877319
• Product Code: LIT
• UDI-Device Identifier: 00801741057618
• UDI-Public: (01)00801741057618
• 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): 01/15/2020

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: U4150415RX
• Device Catalogue Number: U4150415RX
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/15/2020
• Patient Sequence Number: 1