MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	U357554
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the reported malfunction was provided, therefore, a lot history review was performed.The device was returned to the manufacturer for evaluation.Therefore, the investigation is confirmed for the reported balloon rupture and device detachment issue.The definitive root cause for the reported balloon rupture and device detachment could not be determined based upon available information.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates the model u357554 pta balloon dilatation catheter allegedly experienced material rupture and detachment of device or device component.The report was received from a single source.This malfunction involved patient with no known impact to the patient.The patient's age, gender and weight was not provided.

• Brand Name: ULTRAVERSE 035 PTA 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: 10738144
• Report Number: 2020394-2020-06115
• Device Sequence Number: 1926482
• Product Code: LIT
• UDI-Device Identifier: 00801741092459
• UDI-Public: (01)00801741092459
• 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): 10/26/2020

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: U357554
• Device Catalogue Number: U357554
• Device Lot Number: CMDU0394
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/26/2020
• Patient Sequence Number: 1