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

Model Number	ATG120144
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 pta dilatation catheter was returned for evaluation.No specific anomalies noted during the visual evaluation.On the functional test of the device, it was connected to an in-house presto device and the balloon was inflated and it was noted the water was leaking from the distal tip.Further, the balloon was cut and under microscopic observation, it was noted a partial circumferential break was noted to the guide-wire lumen just proximal to the glue bullet.No other functional testing was performed.Therefore, the investigation for the reported balloon rupture remains inconclusive as no evidence could not be noted due to break at the inner guide wire lumen.The investigation was also confirmed for identified leak as water was noted to be leak from the distal tip during the functional testing.The investigation was confirmed for identified catheter tear as a partial circumferential break was noted to the guide-wire lumen just proximal to the glue bullet.A definitive root cause for the reported balloon rupture and identified catheter tear and leak could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.(expiry date: 09/2024).
Event or Problem Description
It was reported that during an angioplasty procedure in the iliac vein, the pta balloon allegedly failed to open in the iliac vein upon attempting to inflate.It was further reported that physician removed the balloon from patient's body and identified leakage of the balloon at the proximal end.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: 14546145
• Report Number: 2020394-2022-00425
• Device Sequence Number: 6736927
• Product Code: DQY
• UDI-Device Identifier: 00801741060762
• UDI-Public: (01)00801741060762
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2022

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 Model Number: ATG120144
• Device Catalogue Number: ATG120144
• Device Lot Number: 93WF0121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 31 YR
• Patient Sex: Male