MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 018 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	U813054
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided and a lot history review has been performed.The device was returned for evaluation and a rip was identified on the side of the packaging indicating a breach.The definitive root cause is unknown.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 u813054 pta balloon dilatation catheter allegedly experienced a packaging issue.This information was received from one source.There was no reported patient contact.Patient information was not provided.

• Brand Name: ULTRAVERSE 018 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: 9219898
• Report Number: 2020394-2019-04292
• Device Sequence Number: 2740019
• Product Code: LIT
• UDI-Device Identifier: 00801741055126
• UDI-Public: (01)00801741055126
• 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: U813054
• Device Catalogue Number: U813054
• Device Lot Number: CMDP0339
• 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