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

Catalog Number ATG80144

Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation; therefore, the investigation is inconclusive for material rupture and detachment 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.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that an unknown atlas gold pta balloon dilatation catheter allegedly experienced a material rupture and detachment.This information was received from one source.The material rupture and detachment involved one patient with no patient consequence.The patient was male; age and weight were not reported.

Manufacturer Narrative

H10: the device was returned for evaluation.The lot number has been provided, and a lot history review was performed.The investigation was confirmed for balloon detachment, however it was inconclusive for balloon rupture.The root cause could not be determined.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that an atg80144, pta balloon dilatation catheter allegedly experienced a material rupture and detachment.This information was received from one source.The material rupture and detachment involved one patient with no patient consequence.The patient was male; age and weight were not reported.

• 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: 8812014
• MDR Text Key: 151740496
• Report Number: 2020394-2019-01658
• Device Sequence Number: 1
• Product Code: LIT
• 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: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: ATG80144
• Device Lot Number: 93XC0200
• Date Manufacturer Received: 09/30/2019
• Patient Sequence Number: 1