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

Model Number ATG80164

Device Problems Break (1069); Retraction Problem (1536); Material Rupture (1546); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

For the reported information, the device was not returned to bd for evaluation.However, a photo was provided for review.The company is still investigating the issue at this time.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 experienced material rupture, material deformation, and retraction problem.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The (b)(6) male patient was (b)(6).

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model atg80164 pta balloon dilatation catheter allegedly experenced material rupture, material deformation, and retraction problem.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The 82 year old male patient was 108 kg.

Manufacturer Narrative

H10: the lot number was provided for malfunction, a lot history review was performed.For the reported information, the device was not returned to bd for evaluation.However, a photo was provided for review.Based on the photo review, a balloon joint break can be confirmed.The investigation is inconclusive for the reported rupture and retraction issue.However, the definite root cause could not be determined based on the available information.The device is labeled for single use.

• 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: 9968321
• MDR Text Key: 189322240
• Report Number: 2020394-2020-02861
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741060816
• UDI-Public: (01)00801741060816
• 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: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• 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: 93ZC0085
• Date Manufacturer Received: 06/29/2020
• Patient Sequence Number: 1