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

Model Number ATG80164

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A lot history review was conducted, and it was determined that a device history record (dhr) review was not required.The investigation is inconclusive for the reported balloon detachment, as the device was not returned for evaluation.The definitive root cause for the reported balloon detachment could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model atg80164 pta balloon dilatation catheter allegedly detached and migrated to the lungs.Forceps were used to retrieve the detached balloon.There was no reported patient injury.This information was received from one source.Patient age, weight, and gender were not provided.

• 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
• Manufacturer (Section G): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens TX 75751
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8809763
• MDR Text Key: 151740566
• Report Number: 2020394-2019-01645
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741060816
• UDI-Public: (01)00801741060816
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2019

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: ATG80164
• Device Catalogue Number: ATG80164
• Device Lot Number: 93PD0018
• Initial Date Manufacturer Received: 06/30/2019
• Initial Date FDA Received: 07/19/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1