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

Model Number	U4150230RX
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
The lot number for the two reported malfunctions was provided, therefore, lot history reviews were performed.The devices were not returned to the manufacturer for evaluation/inspection.Therefore, the investigation for the two reported malfunctions are inconclusive for the alleged material rupture issue.Based on the available information, the definitive root cause is unknown.The devices are labeled for single use.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicates the model u4150230rx pta balloon dilatation catheter allegedly experienced material rupture.The report was received from various source.Both malfunctions were involved patient with no known impact to the patient.Of the two reported malfunctions, one female patient is (b)(6) years old and weighs (b)(6) kgs.The remaining patient's age, gender and weight was not provided.

• Brand Name: ULTRAVERSE RX 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: 10738185
• Report Number: 2020394-2020-06120
• Device Sequence Number: 16625883
• Product Code: LIT
• UDI-Device Identifier: 00801741056383
• UDI-Public: (01)00801741056383
• 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: U4150230RX
• Device Catalogue Number: U4150230RX
• Device Lot Number: CMDY0097,CMDY0063
• 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