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

Model Number	U4200230RX
Medical Device Problem Codes	Break (1069); 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
As the lot number for the device was provided, a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation.Investigation of the returned device confirmed for the reported catheter shaft break.Based on the available information, the definitive root cause for this event is unknown.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 u4200230rx pta balloon dilatation catheter allegedly experienced shaft break.This information was received from one source.The one reported malfunction involved one patient with no consequences.The age of the male patient weighing (b)(6) kgs was not provided.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation.Therefore, the investigation confirmed for the reported detachment of device or device component.Based on the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H11: b5, h6 (device).H11:section a through f: the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model u4200230rx pta balloon dilatation catheter allegedly experienced detachment of device or device component.This information was received from one source.The reported malfunction involved patient with no consequences.A male patient weighs 82 kgs whose age 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: 10734786
• Report Number: 2020394-2020-06064
• Device Sequence Number: 2113434
• Product Code: LIT
• UDI-Device Identifier: 00801741056390
• UDI-Public: (01)00801741056390
• 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): 01/08/2021

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: U4200230RX
• Device Catalogue Number: U4200230RX
• Device Lot Number: CMEP0344
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 01/08/2021
• Patient Sequence Number: 1