MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION STENTS I-CAST; ILIAC COVERED STENT, ARTERIAL

Model Number	42616
Medical Device Problem Codes	Expiration Date Error (2528); Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Report received from distributor stated that the product labeling was found to have an error.The product date of manufacture was listed in the distributor udi barcode label instead of the expiration date of the product.The expiration date on the primary manufacturer product label was correct.
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Corrected information: section d2b - procode.Additional information: section d9, h6 & h10.Related mfg report numbers: 3011175548-2024-00184, -00185, -00186, -00188, -00189, -00190, -00192, -00191, -00193, -00194, -00195.Investigation summary: on 12jul2024, cook medical notified atrium medical corporation of a discrepancy in the distribution label (ls000125) applied during the rework of (b)(6).Specifically, the udi on the distribution label had an incorrect date instead of the expiration date.Because of this incorrect date, the device appeared to be expired when it was not.Cook medical is a new distribution partner to atrium where cook is responsible for distributing all icast products.As part of this new partnership, a new distribution label was added to the boms of icast part numbers.The distribution label provides a barcode to be used by cook for logistics purposes when receiving product.Without this label, icast products cannot be sold to or received by cook since they scan at least 1 label per lot during their receiving process.(b)(6) was originally built without the cook label prior to the implementation of the cook label.Once the cook label was implemented, all icast product in inventory required rework to apply this new cook label.These reworks were performed under ncr005717.During the rework for (b)(6), two errors occurred resulting in the lot being released with the incorrect label.First, an error occurred during the creation of the label and second, during the verification step of the rework to confirm accuracy of the label.The cause is related to the rework process and will be further investigated in corrective and preventative action capa 1101766.

• Brand Name: STENTS I-CAST
• Common Device Name: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 19787631
• Report Number: 3011175548-2024-00187
• Device Sequence Number: 8654480
• Product Code: PRL
• UDI-Device Identifier: 00650862426168
• UDI-Public: 00650862426168
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K050814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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 Model Number: 42616
• Device Catalogue Number: 42616
• Device Lot Number: 508083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 07/20/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown