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

Model Number	U4200220RX
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
Event or Problem Description
This report summarizes one malfunction event.A review of the events indicated that model u4200220rx pta balloon dilatation catheter experienced a detachment of device or device component.This report was received from one source.This event involved one patient with no patient consequences.The patient was male and weighed (b)(6) pounds and was(b)(6) years of age.
Additional Manufacturer Narrative
The device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.The device was returned for evaluation.A visual inspection found the device returned in two segments with a complete detachment in the catheter shaft, confirming the investigation for catheter detachment.The definitive root cause for the identified detachment could not be determined based upon available information.It is unknown whether procedural issues contributed to the event.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction event.A review of the events indicated that model u4200220rx pta balloon dilatation catheter experienced a detachment of device or device component.This report was received from one source.This event involved one patient with no patient consequences.The patient was male and weighed 180 pounds and was 78 years of age.

• Brand Name: ULTRAVERSE RX 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: 8519706
• Report Number: 2020394-2019-00346
• Device Sequence Number: 1278137
• Product Code: LIT
• UDI-Device Identifier: 00801741056338
• UDI-Public: (01)00801741056338
• 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): 07/25/2019

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: U4200220RX
• Device Catalogue Number: U4200220RX
• Device Lot Number: CMCQ0475
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 07/25/2019
• Patient Sequence Number: 1