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

Model Number	U4150330RX
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 two devices, two lot numbers were provided, and lot history reviews were performed.Of the two reported malfunctions, devices were not returned for evaluation.For the reported two malfunctions, the investigation is inconclusive for material 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 two malfunctions.A review of the reported information indicates that model u4150330rx pta dilatation catheter allegedly experienced material rupture.The information was received from various sources.Of the two malfunctions, both involved patients with no patient consequences.The (b)(6) year old male patient weight was not provided.The age, weight, and gender were not provided for another patient.

• Brand Name: ULTRAVERSE RX PTA DILATATION CATHETER
• Common Device Name: PTA DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10305959
• Report Number: 2020394-2020-04802
• Device Sequence Number: 16998396
• Product Code: LIT
• UDI-Device Identifier: 00801741057045
• UDI-Public: (01)00801741057045
• 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): 07/21/2020

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: U4150330RX
• Device Catalogue Number: U4150330RX
• Device Lot Number: CMCU0073, CMCV0054
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/21/2020
• Patient Sequence Number: 1