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

Catalog Number	ATG80144
Medical Device Problem Codes	Break (1069); Material Frayed (1262); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one atlas gold catheter was returned for evaluation.Frayed fibers were noted on the catheter and no other anomalies were noted during the visual evaluation.On functional testing, the returned catheter was inflated with an in-house presto inflation device and water was noted to be leaking from the proximal end of the balloon.Further, under microscopic observations, a partial circumferential break was noted at the proximal end of the balloon and catheter.No other functional testing was performed.One photo was reviewed.The photo shows the balloon's inflated condition and appearing bloody.Water steaming near the catheter can be observed.However, the source of leak couldn¿t be observed due to the quality of the photo.The submitted photo doesn¿t show any significant evidence for the source of leak.However, during the microscopic observations, a partial circumferential break noted between the proximal joint end of the catheter and the balloon caused the leak during the inflation of the catheter during the functional testing.Frayed fibers were also observed during the visual evaluation.Hence, the investigation confirmed the reported leak and identified partial circumferential break at the catheter and balloon proximal end and identified frayed fibers.During the microscopic observations, a partial circumferential break noted between the proximal joint end of the catheter might lead to the reported leak.However, the definitive root cause for the reported leak, identified break and frayed fiber 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 (expiry date: 05/2024) h11: section a through f: the information provide 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 iliac vein, the water was allegedly noted to be leaking between the balloon and the tube body under normal pressure.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one atlas gold catheter was returned for evaluation.Frayed fibers were noted on the catheter and no other anomalies were noted during the visual evaluation.On functional testing, the returned catheter was inflated with an in-house presto inflation device and water was noted to be leaking from the proximal end of the balloon.Further, under microscopic observations, a partial circumferential break was noted at the proximal end of the balloon and catheter.No other functional testing was performed.One photo was reviewed.The photo shows the balloon's inflated condition and appearing bloody.Water steaming near the catheter can be observed.However, the source of leak couldn¿t be observed due to the quality of the photo.The submitted photo doesn¿t show any significant evidence for the source of leak.However, during the microscopic observations, a partial circumferential break noted between the proximal joint end of the catheter and the balloon caused the leak during the inflation of the catheter during the functional testing.Frayed fibers were also observed during the visual evaluation.Hence, the investigation confirmed the reported leak and identified partial circumferential break at the catheter and balloon proximal end and identified frayed fibers.During the microscopic observations, a partial circumferential break noted between the proximal joint end of the catheter might lead to the reported leak.However, the definitive root cause for the reported leak, identified break and frayed fiber 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.H11: section a through f: the information provide 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 iliac vein, the water was allegedly noted to be leaking between the balloon and the tube body under normal pressure.The procedure was completed using another device.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: 18370633
• Report Number: 2020394-2023-01308
• Device Sequence Number: 18037219
• Product Code: DQY
• UDI-Device Identifier: 00801741060755
• UDI-Public: (01)00801741060755(11)210504(17)240504(10)93RF0133
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K181323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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 Expiration Date: 05/04/2024
• Device Catalogue Number: ATG80144
• Device Lot Number: 93RF0133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2021
• 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 Sex: Unknown