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
The lot numbers for the four malfunctions were provided, therefore, lot history reviews will be performed.None of the devices were returned for evaluation.Therefore for the four reported malfunctions, the investigations are inconclusive as no objective evidence was provided for review.A definitive root causes could not be determined.The devices are labeled for single use.
Event or Problem Description
This report summarizes four malfunctions.A review of the reported information indicated that model u4150530rx pta balloon dilatation catheter allegedly experienced a balloon rupture.This information was received from various sources.All malfunctions involved a patient with no reported patient consequence.The malfunction involves two females and one male all other patient information was not provided for any of 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: 10738834
• Report Number: 2020394-2020-06132
• Device Sequence Number: 19648768
• 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): 10/27/2020

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: CMCZ0369, CMCY0427, CMCY0375
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/27/2020
• Patient Sequence Number: 1