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

Catalog Number	ATG120164
Medical Device Problem Codes	Break (1069); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure in the patient's left iliac vein via the left femoral vein access, the pta balloon was allegedly failed to fill properly.It was further reported that there was allegedly a disconnection between the balloon and the delivery system.Furthermore, the balloon and the delivery system were removed from the body together.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: (expiration date: 10/2025).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.
Event or Problem Description
It was reported that during an angioplasty procedure in the patient's left iliac vein via the left femoral vein access, the pta balloon was allegedly failed to fill properly and a rupture was noted.It was further reported that there was allegedly a disconnection between the balloon and the delivery system.Furthermore, the balloon and the delivery system were removed from the body together and they were not completely separated during the removal.The procedure was completed using another device.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: the physical device was not returned for evaluation.One photo was provided and reviewed.The photo shows the atlas gold device.The balloon is seen completely detached from the catheter shaft and inverted.Therefore, the investigation is unconfirmed for the reported break but confirmed for the identified detachment as the balloon was seen completely detached from the rest of the device.The investigation is inconclusive for the reported balloon rupture as no objective evidence was provided.A definitive root cause for the reported balloon rupture, break and identified detachment 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: d2b (dqy;lit).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.

• 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: 19658740
• Report Number: 2020394-2024-00963
• Device Sequence Number: 6624033
• Product Code: DQY
• UDI-Device Identifier: 00801741060823
• UDI-Public: (01)00801741060823(17)251007(10)93XG0004
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 10/21/2024

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: 10/07/2025
• Device Catalogue Number: ATG120164
• Device Lot Number: 93XG0004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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