MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TRUE DILATATION CATHETER; BALLOON VALVULOPLASTY CATHETER

Model Number 0214512

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to bd for evaluation.The company is still investigating the issue at this time.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 214512 balloon valvuloplasty catheter allegedly experienced damaged device prior to use.This information was received from one source.There was no reported patient contact.Patient age, weight, and gender were not provided.

Manufacturer Narrative

H10: the lot number for the malfunction was provided and a lot history review was performed.A lot sample has been returned for evaluation; the evaluation could not identify any damage of the device prior to use.Based upon the available information, a definitive root cause 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.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 214512 balloon valvuloplasty catheter allegedly experienced damaged device prior to use.This information was received from one source.There was no reported patient contact.Patient age, weight, and gender were not provided.

• Brand Name: TRUE DILATATION CATHETER
• Type of Device: BALLOON VALVULOPLASTY CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9194957
• MDR Text Key: 162445989
• Report Number: 2020394-2019-03969
• Device Sequence Number: 1
• Product Code: OZT
• UDI-Device Identifier: 00801741097447
• UDI-Public: (01)00801741097447
• 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: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0214512
• Device Catalogue Number: 0214512
• Device Lot Number: GFDP0770
• Date Manufacturer Received: 12/31/2019
• Patient Sequence Number: 1