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

Model Number	U4150430RX
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 and a lot history review was performed.The device has been returned for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model u4150430rx pta balloon dilatation catheter allegedly experienced detachment.This information was received from one source.This malfunction involved a patient with no consequences.The (b)(6) male patient's weight was not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model u4150430rx pta balloon dilatation catheter allegedly experienced detachment.This information was received from one source.This malfunction involved a patient with no consequences.The 70 year old male patient's weight was not provided.
Additional Manufacturer Narrative
H10: the lot number was provided; therefore, a lot history review was performed.The sample was returned, and the investigation confirmed for device detachment.A definite root cause for the reported event could not be determined.The device was labeled for single use.

• 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: 9975247
• Report Number: 2020394-2020-03012
• Device Sequence Number: 11420220
• Product Code: LIT
• UDI-Device Identifier: 00801741057700
• UDI-Public: (01)00801741057700
• 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): 07/07/2020

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: U4150430RX
• Device Catalogue Number: U4150430RX
• Device Lot Number: CMDY0019
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 04/17/2020
• Supplement Report FDA Received Date: 07/07/2020
• Patient Sequence Number: 1