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

Model Number U4150210RX

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided so a lot history review was performed.The device was not returned to bd for evaluation.The investigation is still underway.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model u4150210rx pta balloon dilatation catheter allegedly experienced a material deformation.This information was received from one source.This malfunction involved a patient with no reported patient injury.The male patient's age and weight were not provided.

Manufacturer Narrative

H10: the lot number was provided so a lot history review was performed.The device has not been returned for evaluation, therefore, the investigation is inconclusive for material deformation as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.H10:g4 h11: h6 (results and conclusion) 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 Description

This report summarizes one malfunction.A review of the reported information indicated that model u4150210rx pta balloon dilatation catheter allegedly experienced a material deformation.This information was received from one source.This malfunction involved a patient with no reported patient injury.The male patient's age and weight were not provided.

• Brand Name: ULTRAVERSE RX PTA DILATATION 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: 9594172
• MDR Text Key: 179280128
• Report Number: 2020394-2020-00418
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741056239
• UDI-Public: (01)00801741056239
• 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: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: U4150210RX
• Device Catalogue Number: U4150210RX
• Device Lot Number: CMDX0385
• Date Manufacturer Received: 03/26/2020
• Patient Sequence Number: 1