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

Model Number	ATG120164
Medical Device Problem Codes	Break (1069); Retraction Problem (1536); Failure to Advance (2524); 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 lot number for the malfunction was provided and a lot history review will be performed.The device for this malfunction has been returned to the manufacturer for evaluation.The evaluation identified detachment of device or device component and failure to advance will be inconclusive.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model atg120164 pta balloon dilatation catheter allegedly experienced failure to advance and detachment of device or device component.This information was received from one source.This malfunction involved one patient with no consequences.The weight of the (b)(6) year old male is (b)(6) kgs.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review will be performed.The device for this malfunction has been returned to the manufacturer for evaluation.The investigation is confirmed for break and retraction issues but remains inconclusive for failure to advance.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 or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model atg120164 pta balloon dilatation catheter allegedly experienced failure to advance, break and retraction problem.This information was received from one source.This malfunction involved one patient with no consequences.The weight of the 59 year old male is 65 kgs.

• 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: 9979795
• Report Number: 2020394-2020-03087
• Device Sequence Number: 2168263
• Product Code: DQY
• UDI-Device Identifier: 00801741060823
• UDI-Public: (01)00801741060823
• 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): 07/09/2020

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: ATG120164
• Device Catalogue Number: ATG120164
• Device Lot Number: 93UD0067
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 04/20/2020
• Supplement Report FDA Received Date: 07/09/2020
• Patient Sequence Number: 1