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

Model Number AT75186

Device Problems Difficult to Remove (1528); Retraction Problem (1536); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model at75186, pta balloon dilation catheter, allegedly became caught in the stent, was difficult to remove from the patient, and experienced unraveled material.This information was received from a single source.This malfunction involved a patient with no consequences.Patient age, weight, and gender were not provided.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model at75186, pta balloon dilation catheter, allegedly became caught in the stent, was difficult to remove from the patient, and experienced unraveled material.This information was received from a single source.This malfunction involved a patient with no consequences.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.The investigation is confirmed for the unraveled fibers and inconclusive for the retraction issue.The definitive root cause could not be determined.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: ATLAS PTA DILATION 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: 9195157
• MDR Text Key: 162445116
• Report Number: 2020394-2019-03980
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741062506
• UDI-Public: (01)00801741062506
• 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: AT75186
• Device Catalogue Number: AT75186
• Device Lot Number: GFCY2820
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/15/2019
• Supplement Dates Manufacturer Received: 12/31/2019
• Supplement Dates FDA Received: 01/07/2020
• Patient Sequence Number: 1