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

Model Number	U415064RX
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 number for both malfunctions was provided and a lot history review was performed.The devices for both malfunctions has not been returned for evaluation, therefore, the investigation is inconclusive for material rupture as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.The devices were labeled for single use.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model u415064rx pta balloon dilatation catheter allegedly experienced material rupture.This information was received from various sources.The malfunctions involved two patients with no consequences.The weight of one (b)(6) year old female is (b)(6) kgs and another patient's information was 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: 9977304
• Report Number: 2020394-2020-03049
• Device Sequence Number: 2077276
• 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
• Report Date (Section B): 04/20/2020

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: CMDY0003, CMCZ0088
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 04/20/2020
• Patient Sequence Number: 1