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

Model Number	U4150315RX
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 device was provided and a lot history review was performed.The investigation is inconclusive for the reported guidewire issue, catheter kink and advancement issue, as the device was not returned for evaluation.The definitive root cause for the reported guidewire issue, catheter kink and advancement issue could not be determined based upon available information.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model u4150315rx pta balloon dilatation catheter allegedly experienced failure to advance, device-device incompatibility, and material deformation.This information was received from one source.One patient was involved and there was no reported patient injury.The male patient is (b)(6) years old and weighs (b)(6) kgs.

• 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: 9216277
• Report Number: 2020394-2019-04215
• Device Sequence Number: 14084290
• Product Code: LIT
• UDI-Device Identifier: 00801741056956
• UDI-Public: (01)00801741056956
• 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): 10/21/2019

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: U4150315RX
• Device Catalogue Number: U4150315RX
• Device Lot Number: CMDQ0320
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/21/2019
• Patient Sequence Number: 1