BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX ZETA CORONARY STENT SYSTEM

    MDR report key: 3836623 · Received May 28, 2014

    Report

    Report Number
    2024168-2014-03365
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 7, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE AND PACKAGING WERE RETURNED FOR EVALUATION. THE PRODUCT MIX-UP WAS CONFIRMED. IN THIS CASE, THERE IS NO INDICATION THAT THE MIX-UP OCCURRED DURING MANUFACTURING OF THE PRODUCTS AT ABBOTT VASCULAR. IT IS POSSIBLE THAT THE 3.0X38MM ZETA POUCH/DEVICE WAS INADVERTENTLY PLACED IN A 3.5X38MM RX ZETA CHIPBOARD BOX AT THE ACCOUNT, ALTHOUGH THIS CANNOT BE CONFIRMED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. ALTHOUGH THE EXACT CAUSE FOR THE MISLABELING/MIX-UP CANNOT BE DETERMINED, THERE IS NO INDICATION OF A MANUFACTURING OR PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ZETA STENT DELIVERY SYSTEM WAS BEING UNPACKED FOR USE; HOWEVER, THE CHIPBOARD BOX WAS LABELED 3.5 X 38 MM, LOT NUMBER 3100441, EXPIRATION 9/2015 AND THE POUCH WAS LABELED 3.0 X 38 MM, LOT NUMBER 3042641, EXPIRATION 3/2015. THE DEVICE WAS LABELED 3.0 X 38, LOT # 3042641. THE DEVICE WAS NOT USED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312571 MULTI-LINK RX ZETA CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 3100441

    Patients

    Seq Age Sex Outcome Treatment
    1