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

Model Number	U351301210
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
One device was returned to bd for evaluation.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction event.A review of the events indicated that model u351301210 pta balloon dilatation catheter experienced a material rupture.This report was received from one source.This event involved one patient with no patient consequences.Patient age, weight, and gender were not provided.
Event or Problem Description
This report summarizes one malfunction event.A review of the events indicated that model u351301210 pta balloon dilatation catheter experienced a material rupture.This report was received from one source.This event involved one patient with no patient consequences.Patient age, weight, and gender were not provided.
Additional Manufacturer Narrative
One device was returned to bd for evaluation.A visual inspection found a longitudinal rupture the length of the balloon.Therefore, the investigation is confirmed for the reported rupture.The definitive root cause for the identified rupture could not be determined based upon available information.The device is labeled for single use.

• Brand Name: ULTRAVERSE 035 PTA BALLOON 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: 8516487
• Report Number: 2020394-2019-00327
• Device Sequence Number: 1870977
• Product Code: LIT
• UDI-Device Identifier: 00801741094972
• UDI-Public: (01)00801741094972
• 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,Followup
• Report Date (Section B): 07/23/2019

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: U351301210
• Device Catalogue Number: U351301210
• Device Lot Number: CMCR0359
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1