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

Model Number	U4200210RX
Medical Device Problem Code	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 malfunction was provided; therefore, a lot history review is currently being performed.The device was returned for evaluation.Therefore, the investigation is confirmed for catheter detachment.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.The catalog number identified has not been cleared in the us, but is similar to the ultraverse rx pta dilatation catheter products that are cleared in the us.The pro code for the ultraverse rx pta dilatation catheter products is identified.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model u4200210rx pta balloon dilatation catheter allegedly experienced catheter detachment.This report was received from one source.This malfunction involved one patient with no patient consequences.Age, weight, and gender were 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: 10308374
• Report Number: 2020394-2020-04895
• Device Sequence Number: 14295599
• Product Code: LIT
• UDI-Device Identifier: 00801741056246
• UDI-Public: (01)00801741056246
• 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: U4200210RX
• Device Catalogue Number: U4200210RX
• Device Lot Number: CMDW0212
• 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