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

Model Number	ATG120146
Medical Device Problem Codes	Material Frayed (1262); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure through right internal jugular vein, the pta balloon allegedly had a pin hole rupture after five inflations.There was no reported patient injury.
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: two photos were provided and reviewed.The first photo shows the atlas gold balloon.Frayed fibers are noted on the balloon.The second photo shows the atlas gold balloon.A pinhole rupture is noted on the balloon.Therefore, based on the submitted photos, the reported uncomplicated pinhole balloon rupture and identified material frayed can be confirmed.One atlas gold pta dilatation catheter was returned for evaluation.During visual evaluation, no kinks were noted to the catheter shaft and no anomalies to the luers/y-body.Under microscopic evaluation at 50x, a pinhole rupture, frayed fibers and fiber disturbance were noted.Therefore, the investigation is confirmed for the reported uncomplicated pinhole balloon rupture since a pinhole rupture was noted on the balloon under microscopic evaluation.The investigation is confirmed for the identified material frayed since frayed fibers were noted on the balloon under microscopic evaluation.A definitive root cause for the alleged reported uncomplicated pinhole balloon rupture and identified material frayed 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.Expiration date: 06/2024.

• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13083297
• Report Number: 2020394-2021-02107
• Device Sequence Number: 17501047
• Product Code: DQY
• UDI-Device Identifier: 00801741060786
• UDI-Public: (01)00801741060786
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 12/16/2021

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: ATG120146
• Device Catalogue Number: ATG120146
• Device Lot Number: 93SF0158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 12/24/2021
• 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 Sex: Unknown