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

Model Number ATG80144

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the malfunction was provided and a lot history review was performed.The device for this malfunction has been returned to the manufacturer for evaluation.The investigation of the reported malfunction is currently underway.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model atg80144 pta balloon dilatation catheter allegedly experienced material unraveled, restriction problem and difficult to remove.This information was received from one source.This malfunction involved one patient with no consequences.The patient's age, weight and gender were not provided.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model atg80144 pta balloon dilatation catheter allegedly experienced material unraveled, restriction problem and difficult to remove.This information was received from one source.This malfunction involved one patient with no consequences.The patient's 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 device for this malfunction has been returned to the manufacturer for evaluation.The investigation confirmed for failure unraveled and inconclusive for retraction problem.The definitive root cause is unknown.The device is labeled for single use.H10: g4 , h6(device: 1262).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 GOLD 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: 9973174
• MDR Text Key: 188088575
• Report Number: 2020394-2020-02951
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741060755
• UDI-Public: (01)00801741060755
• 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: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ATG80144
• Device Catalogue Number: ATG80144
• Device Lot Number: 93ZD0095
• Date Manufacturer Received: 06/29/2020
• Patient Sequence Number: 1