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

Catalog Number	ATG120146
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure in the left iliac, after the inflation when trying to remove the sheath, the device allegedly met some resistance, and the pta balloon was allegedly sheared off the sheath.It was further reported that the balloon was tried to be snared but was unsuccessful.Reportedly, the balloon was able to stuck out with 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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiry date: 11/2025).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.
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, residue was noted throughout the device.The balloon was noted inverted and completely detached from the catheter shaft.Bunching was noted throughout the balloon.Due to the nature of the complaint, functional testing was not performed.Therefore, the investigation is confirmed for the reported balloon detachment and removal difficulty as the device was received with the balloon completely detached and inverted, which would have occurred due to difficulties during removal.A definitive root cause for the alleged balloon detachment and removal difficulty 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.H10: d4 (expiry date: 11/2025), g3, h6 (method).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 left iliac, after the inflation when trying to remove the sheath, the device allegedly met some resistance, and the pta balloon was allegedly sheared off the sheath.It was further reported that the balloon was tried to be snared but was unsuccessful.Reportedly, the balloon was able to stuck out with another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: our firm received an fda email correspondence on 8-july-2024 from mdr data systems team, latania parker, indicating that the information (specifically the unique device identifier (udi) information in section d) of the previously submitted fda form 3500a, was incorrect and a request was made to submit supplemental report(s) with the entire udi number including the di and pi fields, all numbers, letters, parentheses, and symbols in the "unique device identifier (udi) #" fields.This supplemental report is in response to that request.H11: d2: medical device type-lit; dqy.D4: medical device expiration date- 11/29/2025.D4: udi: (b)(4).H4: device manufacture date-11/29/2022.G4: pma/510(k): k122984; k181323.
Event or Problem Description
It was reported that during an angioplasty procedure in the left iliac, after the inflation when trying to remove the sheath, the device allegedly met some resistance, and the pta balloon was allegedly sheared off the sheath.It was further reported that the balloon was tried to be snared but was unsuccessful.Reportedly, the balloon was able to stuck out with 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): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18189827
• Report Number: 2020394-2023-01086
• Device Sequence Number: 7264434
• Product Code: LIT
• UDI-Device Identifier: 00801741060786
• UDI-Public: (01)00801741060786(11)221129(17)251129(10)93YG0153
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K122984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2024
• 2 Devices were Involved in the Event: 1 2

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: 11/29/2025
• Device Catalogue Number: ATG120146
• Device Lot Number: 93YG0153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 02/15/2024; 07/08/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 02/24/2024; 07/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2022
• 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: 37 YR
• Patient Sex: Female