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

Model Number	U3575510
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
Of the 3 devices, 3 lot numbers were provided, and lot history reviews were performed.Of the 3 reported malfunctions, devices were not returned for evaluation.For the reported three malfunctions, the investigation is inconclusive for rupture.Based upon the available information, the definitive root cause is unknown.The devices were labeled for single use.
Event or Problem Description
This report summarizes three malfunctions.A review of the reported information indicates that model u3575510 pta dilatation catheter allegedly experienced material rupture.The information was received from various sources.All three malfunctions involved patients with no patient consequences.The age and weight of the three female patients were 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: 10309746
• Report Number: 2020394-2020-04943
• Device Sequence Number: 10977939
• Product Code: LIT
• UDI-Device Identifier: 00801741092480
• UDI-Public: (01)00801741092480
• 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): 07/22/2020

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: U3575510
• Device Catalogue Number: U3575510
• Device Lot Number: CMDY0341, CMDZ0092
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/22/2020
• Patient Sequence Number: 1