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

Model Number ATG80164

Device Problems Retraction Problem (1536); 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 lot number was provided so a lot history review was performed.The device was not returned to bd for evaluation.The investigation is inconclusive for material rupture, retraction problem, and detachment since no sample was provided.Based on the information provided, the definitive root cause in unknown.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, detachment, and a retraction problem.This information was received from one source.This malfunction involved a patient with no reported patient injury.The patient was a (b)(6) year old male that weighed (b)(6) kgs.

Manufacturer Narrative

H10: the lot number was provided so a lot history review was performed.The device was not returned to bd for evaluation.The investigation is inconclusive for material rupture, retraction problem, and detachment since no sample was provided.Based on the information provided, the definitive root cause in 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 reported information indicated that model atg80164 pta balloon dilatation catheter allegedly experienced detachment of device or device component.This information was received from one source.This malfunction involved a patient with no reported patient injury.The patient was a 42 year old male that weighed 105 kgs.

• 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: 9593292
• MDR Text Key: 178786227
• Report Number: 2020394-2020-00344
• 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: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• 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: 93QC0028
• Date Manufacturer Received: 03/31/2020
• Patient Sequence Number: 1