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

Model Number ATG80124

Device Problems Material Frayed (1262); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided for the reported malfunction; therefore, a lot history review is currently being performed.The device was returned to the manufacturer for evaluation.Therefore, the investigation is identified for retraction issue and frayed material.The definitive root cause is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the malfunction indicated that model atg80124 pta balloon dilatation catheter allegedly had a retraction issue and frayed material.This report was received from one source.One patient was involved with no reported patient injury.The device was used in a male patient.Age and weight was not provided.

Manufacturer Narrative

H10: the lot number was provided for the reported malfunction; therefore, a lot history review was performed.The device was returned to the manufacturer for evaluation.The investigation is confirmed for the reported frayed balloon material, however the investigation is unconfirmed for the retraction problem.The definitive root cause is unknown.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.

Event Description

This report summarizes one malfunction.A review of the malfunction indicated that model atg80124 pta balloon dilatation catheter allegedly had a retraction issue and frayed material.This report was received from one source.One patient was involved with no reported patient injury.The device was used in a male patient.Age and weight was 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
• MDR Report Key: 10300310
• MDR Text Key: 199661929
• Report Number: 2020394-2020-04675
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741060694
• UDI-Public: (01)00801741060694
• 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: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ATG80124
• Device Catalogue Number: ATG80124
• Device Lot Number: 93XD0090
• Date Manufacturer Received: 09/30/2020
• Patient Sequence Number: 1