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

Model Number 0264513

Device Problems Leak/Splash (1354); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was not provided so a lot history review could not be performed.The device was returned to bd for evaluation.The investigation identified for material rupture.Based on the information provided, the definitive root cause in unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 0264513 pta balloon dilatation catheter allegedly experienced material rupture.This information was received from one source.This malfunction involved a patient with no reported patient injury.The patient's age, weight, and gender were not provided.

Manufacturer Narrative

H10: the lot number was not provided so a lot history review could not be performed.The device was returned to bd for evaluation.The investigation identified for leak.Based on the information provided, the definitive root cause in unknown.However, the reported malfunction has been reassessed for reportability and determined to be no longer reportable.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 0264513 pta balloon dilatation catheter allegedly experienced material rupture.This information was received from one source.This malfunction involved a patient with no reported patient injury.The patient's age, weight, and gender were not provided.

• Brand Name: TRUE 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: 9572519
• MDR Text Key: 174535064
• Report Number: 2020394-2020-00186
• Device Sequence Number: 1
• Product Code: OZT
• UDI-Device Identifier: 00801741096631
• UDI-Public: (01)00801741096631
• 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: 03/30/2020

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: 0264513
• Device Catalogue Number: 0264513
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/09/2020
• Supplement Dates Manufacturer Received: 03/24/2020
• Supplement Dates FDA Received: 04/01/2020
• Patient Sequence Number: 1