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

Catalog Number	ATG80204
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
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.The investigation of the reported event is currently underway.H10: d4 (expiry date: 05/2025).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.
Event or Problem Description
It was reported that prior to an angioplasty procedure, the expiry date on the product was allegedly incorrect.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed.The dhr review determined the correct expiration date of the product was 2024-05-13.Investigation summary: one electronic photo of a portion the outer product labeling was provided by the user.The label can seen with an expiration date of 2024-05-13.The atlas gold device was also returned for evaluation.The label matched the information reported in the complaint record, and it was noted the printed expiration date was 2024-05-13.The expiration date printed on the labeling matches the expiration date of the product identified in the dhr review of 2024-05-13.Additionally, the manufacturing scanned labeling confirmed the correct expiration date of 2024-05-13.The provided manufacturing certificate of conformance has the expiration date incorrectly entered as 2025-05-13.This is manually entered at the manufacturing facility.The incorrect date was entered on the lot coc and in the sap/jde system.Therefore, the labeling review can confirm that all printed product labeling contained the correct expiration date and the complaint can be unconfirmed.No printed product issue was identified.The root cause of the incorrect date in the sap and jde system was linked to the incorrect date on the lot certificate of conformance.Although no product defect was identified, a process issue was confirmed due to the incorrect expiration date entered on the coc and in the sap and jde systems.Labeling review: one electronic photo of a portion the outer product labeling was provided by the user.The label can seen with an expiration date of 2024-05-13.This expiration date printed on the labeling matches the expiration date of the product identified in the dhr review.Additionally, the manufacturing scanned labeling confirmed the correct expiration date of 2024-05-13.The manufacturing certificate of conformance has the expiration date incorrectly entered as 2025-05-13.This is manually entered at the manufacturing facility.Therefore, the labeling review can confirm that all printed product labeling contained the correct expiration date.The incorrect date was entered on the lot coc and in the sap/jde system.No printed product issue was identified.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.
Event or Problem Description
It was reported that prior to an angioplasty procedure, the expiry date on the product was allegedly incorrect.There was no patient contact.

• 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: 19738847
• Report Number: 2020394-2024-01030
• Device Sequence Number: 7991685
• Product Code: DQY
• UDI-Device Identifier: 00801741060939
• UDI-Public: (01)00801741060939(11)220513(17)240513(10)93SG0029
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 10/15/2024

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: 05/13/2024
• Device Catalogue Number: ATG80204
• Device Lot Number: 93SG0029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2022
• 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