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

Model Number	U415064RX
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported event, lot number was provided, and lot history review.The sample return is pending for evaluation.The company is still investigating the issue at this time.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 u415064rx pta balloon dilation catheter allegedly experienced material deformation and failure to advance.This report was received from a single source.This event did involve patient with no reported patient injury.Age, weight, and gender were not provided for the patient.
Additional Manufacturer Narrative
H.10.For the reported event, lot number was provided, and a lot history review was performed.The sample was returned for evaluation and upon inspection, the alleged malfunction was confirmed.Based on the available information, a definitive root cause for the alleged malfunction could not be determined.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 u415064rx pta balloon dilation catheter allegedly experienced material deformation and failure to advance.This report was received from a single source.This event did involve patient with no reported patient injury.Age, weight, and gender were not provided for the patient.

• Brand Name: ULTRAVERSE RX PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9963235
• Report Number: 2020394-2020-02693
• Device Sequence Number: 16263633
• Product Code: LIT
• UDI-Device Identifier: 00801741058066
• UDI-Public: (01)00801741058066
• 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,Followup
• Report Date (Section B): 07/06/2020

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: U415064RX
• Device Catalogue Number: U415064RX
• Device Lot Number: CMCR0143
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 07/06/2020
• Patient Sequence Number: 1