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

Model Number	ATG120124
Medical Device Problem Codes	Material Frayed (1262); Difficult to Remove (1528); Material Rupture (1546); Unraveled Material (1664); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2022
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 a photo was provided for review.The investigation of the reported event is currently underway.(expiration date: 09/2024).
Event or Problem Description
It was reported that during an angioplasty procedure via femoral, the balloon was allegedly ruptured during dilatation around 5-6 atm.It was further reported that the balloon was allegedly unable to refold.Reportedly, the balloon was allegedly separated from the catheter.The device and introducer sheath were removed as one unit.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 pta dilatation catheter was received for evaluation.During visual evaluation, the balloon was noted to be detached from the proximal and distal glue weld and appeared to be prolapsed on the distal end.Balloon material was noted at both glue welds.The marker bands were noted to be present and seated on the guide-wire lumen.Unraveling was noted to the proximal end of the balloon.Under microscopic evaluation, fiber disturbance and a pinhole rupture were noted to the balloon.No kinks were noted to the catheter shaft and no anomalies were noted to the luers/y-body.Due to the condition of the device and the nature of the complaint, functional testing was not performed.One photo was provided and reviewed.The photo shows the atlas gold balloon detached and prolapsed at its distal end.Frayed fibers and unraveling can be seen at the proximal end of the balloon.Therefore, the investigation is confirmed for the reported balloon rupture as a pinhole rupture was noted to the balloon under microscopic observation.The investigation is also confirmed for the reported detachment as the balloon was noted to be detached from the proximal and distal glue weld.The investigation is inconclusive for the reported difficult to remove as no evidence of the failure could be determined.The investigation is confirmed for the identified frayed fibers and unraveled material as frayed fibers and unraveling were noted to the proximal end of the balloon.A definitive root cause for the reported balloon rupture, difficult to remove, detachment and identified unraveled material and 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.H10: d4 (expiration date: 09/2024).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.
Event or Problem Description
It was reported that during an angioplasty procedure via femoral through little calcified lesion, the pta balloon allegedly ruptured during dilatation around 5-6 atm.It was further reported that the balloon was allegedly unable to refold and go through the sheath.Reportedly, the balloon separated from the catheter.The device and introducer sheath were removed as one unit.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: 14727881
• Report Number: 2020394-2022-00480
• Device Sequence Number: 2264124
• Product Code: DQY
• UDI-Device Identifier: 00801741060700
• UDI-Public: (01)00801741060700
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 06/28/2022

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: ATG120124
• Device Catalogue Number: ATG120124
• Device Lot Number: 93WF0057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 07/21/2022
• 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: 52 YR
• Patient Sex: Female