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

Model Number U354064

Device Problems Material Rupture (1546); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 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 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.

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
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9199596
• MDR Text Key: 162622620
• Report Number: 2020394-2019-04022
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741092893
• UDI-Public: (01)00801741092893
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: No Information
• Device Model Number: U354064
• Device Catalogue Number: U354064
• Device Lot Number: CMCX0364
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/16/2019
• Supplement Dates Manufacturer Received: 12/31/2019
• Supplement Dates FDA Received: 01/07/2020
• Patient Sequence Number: 1