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

Model Number	ATG80146
Medical Device Problem Codes	Deflation Problem (1149); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The one device belonging to the sole complaint is expected to be returned to bd for evaluation.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes 1 malfunction event.A review of the events indicated that model atg80146 dilatation catheter experienced a deflation issue and a detachment of device or component.This event was reported from a single source.This event involved a patient with no reported injury.The patient¿s age, weight, and sex were not provided.
Additional Manufacturer Narrative
H10: the device has been returned for evaluation; the investigation is confirmed for balloon detachment.However, the investigation is inconclusive for the reported deflation issue as the balloon was unable to be functionally tested due to the detached balloon.The definitive root cause for the reported or identified issues could not be determined based on the available information.H10: g4 h11: h6(methods, 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 or Problem Description
This report summarizes 1 malfunction event.A review of the events indicated that model atg80146 dilatation catheter experienced a deflation issue and a detachment of device or component.This event was reported from a single source.This event involved a patient with no reported injury.The patient¿s age, weight, and sex were not provided.

• Brand Name: ATLAS GOLD PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8515354
• Report Number: 2020394-2019-00295
• Device Sequence Number: 13943780
• Product Code: LIT
• UDI-Device Identifier: 00801741060779
• UDI-Public: (01)00801741060779
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2019

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
• Operator of Device: No Information
• Device Model Number: ATG80146
• Device Catalogue Number: ATG80146
• Device Lot Number: 93WC0121
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1