MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 018 PTA BALLOON DILATATION CATHETERS

Model Number	U8150230
Medical Device Problem Codes	Retraction Problem (1536); Material Rupture (1546); 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 was provided and a lot history review was performed.The device was returned for evaluation and the investigation identified detachment of device or device component.A root cause could not be determined.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.The information reviewed indicated that model u8150230 pta balloon dilatation catheter allegedly experienced retraction problem, material rupture, and detachment of device or device component.The information was received from one source.The malfunction involved a (b)(6) year old male patient weighing (b)(6) kgs with no reported consequences.
Additional Manufacturer Narrative
H10: the lot number was provided and a lot history review was performed.The device was returned for evaluation.Based on the sample evaluation, the investigation is confirmed for detachment, material deformation and guide wire issue; however, the investigation is inconclusive for material rupture and retraction issue.A definitive root cause could not be determined.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.The information reviewed indicated that model u8150230 pta balloon dilatation catheter allegedly experienced retraction problem, material rupture, and detachment of device or device component.The information was received from one source.The malfunction involved a 75 year old male patient weighing 75kgs with no reported consequences.

• Brand Name: ULTRAVERSE 018 PTA BALLOON DILATATION CATHETERS
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9975394
• Report Number: 2020394-2020-03033
• Device Sequence Number: 11420384
• Product Code: LIT
• UDI-Device Identifier: 00801741064746
• UDI-Public: (01)00801741064746
• 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): 07/06/2020

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: U8150230
• Device Catalogue Number: U8150230
• Device Lot Number: CMDU0242
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 04/17/2020
• Supplement Report FDA Received Date: 07/06/2020
• Patient Sequence Number: 1