MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	U354064
Medical Device Problem Codes	Material Rupture (1546); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided for the reported malfunction; therefore a review of the device history records is currently being performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon 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.The information reviewed indicated that model u354064 pta balloon dilatation catheter allegedly experienced failure to advance and a rupture.This report was received from one source.The device was used in a (b)(6) year old female patient, 75 kgs.There was no reported patient injury.
Event or Problem Description
This report summarizes one malfunction.The information reviewed indicated that model u354064 pta balloon dilatation catheter allegedly experienced failure to advance and a rupture.This report was received from one source.The device was used in a 73 year old female patient, 75 kgs.There was no reported patient injury.
Additional Manufacturer Narrative
H10: the lot number was provided for the reported malfunction; therefore a review of the device history records is currently being performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.The reported malfunction was reassessed and determined to be not reportable, however, mdr 2020394-2019-04022 was submitted and accepted by the fda on 10/16/2019, this file will remain reportable as a malfunction.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.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.

• Brand Name: ULTRAVERSE 035 PTA 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: 9199596
• Report Number: 2020394-2019-04022
• Device Sequence Number: 3058086
• Product Code: LIT
• UDI-Device Identifier: 00801741092893
• UDI-Public: (01)00801741092893
• 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): 01/07/2020

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: U354064
• Device Catalogue Number: U354064
• Device Lot Number: CMCX0364
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 01/07/2020
• Patient Sequence Number: 1