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

Catalog Number	ATG80124
Medical Device Problem Codes	Crack (1135); Material Puncture/Hole (1504); Material Rupture (1546); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4: (expiration date: 07/2026).H11: section a: through f: the information provided by bd represents all 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
It was reported that during an angioplasty procedure in the subclavian vein via the right arm fistula, the pta balloon allegedly had a hole in the guidewire lumen through which the guidewire kept going through.The procedure was completed using another balloon.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one atlas gold pta dilatation catheter received for evaluation.During visual analysis, balloon kink, bunching in proximal side, and crack in the inflation luer could be observed.No other anomalies were noted.On functional testing, the balloon was inflated by the in-house presto inflation device and could be noted with leak from the balloon.Further an in-house guidewire inserted through the distal tip guidewire luer but the inhouse guidewire could not be exited from the balloon either it went inside of balloon without exiting.Another attempt of inhouse guidewire insertion could be observed with strong resistance and deformation of the inner guidewire lumen inside the balloon.Further the balloon was cut and open, and could be identified with a hole, a partial circumferential break, and kink in the inner guidewire lumen.No other testing was performed.The visual analysis of return sample could be noted with an inflation luer crack, balloon bunch, and kink.Further, the functional testing could be observed with the deformation, hole in the inner guidewire lumen, and leak from the balloon.Therefore, the investigation was confirmed for the identified inflation luer crack, balloon material deformation, balloon rupture and reported inner guidewire lumen hole.A definitive root cause for the reported inner guidewire lumen hole and identified inflation luer crack, balloon and inner guidewire lumen deformation, balloon rupture issues could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 07/2026), g3, h6 (device).H11: section a through f ¿ the information provided by bd represents all 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
It was reported that during an angioplasty procedure in the subclavian vein via the right arm fistula, the pta balloon allegedly had a hole in the guidewire lumen through which the guidewire kept going through.The procedure was completed using another balloon.There was no reported patient injury.

• Brand Name: ATLAS GOLD
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens 75751
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 19077518
• Report Number: 2020394-2024-00477
• Device Sequence Number: 14926917
• Product Code: DQY
• UDI-Device Identifier: 00801741060694
• UDI-Public: (01)00801741060694
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K181323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2024

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: Health Professional
• Device Catalogue Number: ATG80124
• Device Lot Number: 93UH0122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/15/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 06/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male