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

Catalog Number	ATG80222
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
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 will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: d4 (expiration date: 08/2026) 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 prior to an angioplasty procedure, it was noticed that the three codes with the information allegedly does not have barcodes.There was no patient contact.
Additional Manufacturer Narrative
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: the physical device was not returned for evaluation.The atlas gold labeling label artwork document was reviewed, and the updated label revision 3 including a barcode on the device was implemented on 10/31/2023 at the manufacturing facility.The previous label prior to this date did not include a barcode.Per the device device history records review, this lot was manufactured and released on 08/02/2023.Therefore, this lot would have used revision 2, which did not contain a barcode.Therefore, the investigation is unconfirmed for the reported missing barcode as the product labeling contains all correct information based on the date of manufacture.The barcode was added to the labeling after the manufacture date of this lot.The cause of the reported event is likely this change in labeling being unknown to the reporter.Labeling review: atlas gold label artwork document was reviewed.Revision 3 was the first revision to include a barcode on the outer product labeling.Revision 2 did not contain this barcode on the label.Revision 3 was implemented at the manufacturing facility on 10/31/2023.Per the device history records review, this lot was manufactured and released on 08/02/2023.Therefore, this lot would have used revision 2, which did not contain a barcode.As a result of the labeling review, it can be determined that no labeling issue can be confirmed as the product labeling contains all correct information based on the date of manufacture.D4 expiration date: 08/2026.D2b dqy;lit.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 prior to an angioplasty procedure, it was noticed that the three codes with the information allegedly does not have barcodes.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: 19621585
• Report Number: 2020394-2024-00934
• Device Sequence Number: 8121443
• Product Code: DQY
• UDI-Device Identifier: 00801741060953
• UDI-Public: (01)00801741060953
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2024

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 Catalogue Number: ATG80222
• Device Lot Number: 93UH0186
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2023
• 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