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

Catalog Number	ATG120144
Medical Device Problem Codes	Inflation Problem (1310); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one atlas gold pta dilatation catheter was received for evaluation.During visual evaluation, kinks and twisting were noted to the catheter shaft.A kink was also noted at the balloon's proximal end, and a split was observed to the balloon's distal tip.No anomalies to the luers/y-body.During functional evaluation, an in-house presto inflation device was used to inflate the balloon to 18 atm.The balloon was inflated and maintained pressure, the balloon was then deflated without issue.No other functional testing was performed.Therefore, the investigation is unconfirmed for the alleged inflation issue as the balloon was inflated and deflated with no issue.However, the investigation is confirmed for the identified shaft damage and balloon kink as kinks and twisting were noted to the catheter, and a kink was noted at the balloon's proximal end.The investigation is also confirmed for the identified split tip as a split was observed at the balloon's tip.A definitive root cause for the alleged inflation issue, identified shaft damage, balloon kink and split tip 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 (expiration date: 10/2025) h11: section a through f ¿ the information provided by bd represents all 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, the device allegedly had an inflation issue.The procedure was completed using 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, (b)(6), 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-dqy; lit.D4: medical device expiration date- 10/11/2025.D4: udi- (b)(6).H4: device manufacture date- 10/11/2022.G4: k122984; k181323.
Event or Problem Description
It was reported that during an angioplasty procedure, the device allegedly had an inflation issue.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: 18280654
• Report Number: 2020394-2023-01152
• Device Sequence Number: 6696497
• Product Code: DQY
• UDI-Device Identifier: 00801741060762
• UDI-Public: (01)00801741060762(11)221011(17)251011(10)93XG0003
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 07/16/2024

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: 10/11/2025
• Device Catalogue Number: ATG120144
• Device Lot Number: 93XG0003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2023
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 07/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2022
• 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 Sex: Unknown