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

Model Number	U41502H30
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for one of the two reported malfunctions was provided and a lot history review was performed.The device for one malfunction was not returned for evaluation, therefore the investigation is inconclusive for the reported failure.For the other malfunction, the device was returned and the investigation identified peeled outer layer.The definitive root cause is unknown.The devices are labeled for single use.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model u4102h30 pta balloon dilatation catheter allegedly experienced peeled material.This information was received from various sources.Both events involved a patient with no reported patient injury.Patient age, weight, and gender were 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: 9219899
• Report Number: 2020394-2019-04290
• Device Sequence Number: 19516379
• Product Code: LIT
• UDI-Device Identifier: 00801741064449
• UDI-Public: (01)00801741064449
• 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): 10/22/2019

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: U41502H30
• Device Catalogue Number: U41502H30
• Device Lot Number: CMDT0579, UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/22/2019
• Patient Sequence Number: 1