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

Model Number ATG80144

Device Problems Retraction Problem (1536); Material Rupture (1546); Unraveled Material (1664); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The one device belonging to the sole malfunction is expected to be returned to bd for evaluation.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 atg80144 pta balloon dilatation catheter allegedly experienced a material rupture and a detachment of device or device component.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient was reported as a (b)(6) year old male whose weight was not provided.

Manufacturer Narrative

H10: the lot number for the malfunction was provided and a lot history review was performed.The malfunction was reassessed and the trending codes were updated.The device has been returned for evaluation; the evaluation confirmed 1536 - retraction problem and 2907 - detachment of device or device component and was inconclusive for 1546 - material rupture.Based upon the available information, a definitive root cause is unknown.The device is labeled for single use.H10: g4 h11: h6 (device code, results, conclusion) 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 atg80144 pta balloon dilatation catheter allegedly experienced a material rupture, detachment of device, material separation, and unraveled material.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient was reported as a 53-year-old male whose weight was not provided.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model atg80144 pta balloon dilatation catheter allegedly experienced a material rupture, detachment of device, material separation, and unraveled material.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient was reported as a 53-year-old male whose weight was not provided.

Manufacturer Narrative

H10: the sample has been received for evaluation.The company is still investigating the issue at this time.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.

• 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: 9215813
• MDR Text Key: 163132229
• Report Number: 2020394-2019-04178
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741060755
• UDI-Public: (01)00801741060755
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ATG80144
• Device Catalogue Number: ATG80144
• Device Lot Number: 93UD0064
• Date Manufacturer Received: 03/30/2020
• Patient Sequence Number: 1