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

Model Number	ATG120222
Medical Device Problem Codes	Material Frayed (1262); Material Rupture (1546); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation as well as photos were provided for review.The investigation of the reported event is currently underway.(expiration date: 02/2023).
Event or Problem Description
It was reported that during an angioplasty procedure in the right femoral vein, the balloon allegedly had circumferential rupture at 14 atm.The procedure was completed using same device.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure in the right femoral vein, the pta balloon allegedly had circumferential rupture at 14 atm.The procedure was completed using same 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 pta dilatation catheter was received for evaluation.During visual evaluation, a partial circumferential rupture was noted to the balloon.Under microscopic observation, frayed fibers and unraveling were noted at the partial circumferential rupture.No kinks noted to the catheter shaft and no anomalies to the luers/y-body.Functional testing could not be performed due to the condition of the returned device.One photo was provided and reviewed.The photo shows an atlas gold pta balloon.A partial circumferential rupture is noted on the balloon.Therefore, the investigation is confirmed for the reported circumferential balloon rupture.Therefore, the investigation is confirmed for the reported partial circumferential balloon rupture as a partial circumferential rupture was noted to the balloon during visual evaluation.Therefore, the investigation is confirmed for the identified frayed fibers as frayed fibers were noted at the partial circumferential rupture under microscopic observation.Therefore, the investigation is confirmed for the identified unraveling fibers as unraveling fibers were noted at the partial circumferential rupture under microscopic observation.A definitive root cause for the reported partial circumferential balloon rupture, identified frayed fibers and unraveling fibers 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.H10: d4 (expiration date: 02/2023).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.H3 other text : see h10.

• 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: 13819785
• Report Number: 2020394-2022-00186
• Device Sequence Number: 2201163
• Product Code: DQY
• UDI-Device Identifier: 00801741060960
• UDI-Public: (01)00801741060960
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/18/2022

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: ATG120222
• Device Catalogue Number: ATG120222
• Device Lot Number: 93PE0056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/21/2022
• Supplement Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 03/19/2022
• Supplement Report FDA Received Date: 04/20/2022
• 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 Sex: Unknown