MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	U41502H22
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 one malfunction was provided and a lot history review was performed.The devices have not been returned for evaluation, therefore, the four malfunctions are inconclusive as no objective evidence has been provided to confirm any alleged deficiency.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes four malfunctions.A review of the reported information indicated that model u41502h22 pta balloon dilatation catheter allegedly experienced a material rupture.This information was received from various sources.The four malfunctions involved two patients with no patient consequences.One patient was reportedly a 60 year old male of unknown weight.The age, weight, and gender of the other patient was not provided.

• Brand Name: ULTRAVERSE 014 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: 9979835
• Report Number: 2020394-2020-03105
• Device Sequence Number: 2168270
• Product Code: LIT
• UDI-Device Identifier: 00801741053658
• UDI-Public: (01)00801741053658
• 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: U41502H22
• Device Catalogue Number: U41502H22
• Device Lot Number: CMBU0120, UNKNOWN
• 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