BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1053467 · Received May 28, 2008

    Report

    Report Number
    2024168-2008-00430
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    April 28, 2008
    Report Date
    April 28, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    PO20047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT A VISION BOX WAS RETURNED WITH A 3.0X12 LABEL. THE PART NUMBER WAS 1007842-12 AND THE LOT NUMBER WAS 7110732. THE POUCH INSIDE THE BOX WAS UNOPENED AND WAS THAT OF A 3.0X23 VISION. THE PART NUMBER WAS 1007842-23 AND THE LOT NUMBER WAS 7110831. THE CATHETER HUB WAS THAT OF A 3.0X23 VISION AND THE LOT NUMBER ON THE HUB WAS 7110831. THERE WAS NO DAMAGE NOTED TO THE POUCH OR BOX. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO AND ANALYSIS OF THE RETURNED RX VISION SDS. AN INVESTIGATION OF THE LOT HISTORY RECORD REVEALED THAT BOTH OF THE LOTS IDENTIFIED ABOVE, ARE LISTED ON THE SAME NON-CONFORMING MATERIAL REPORT (NCMR). A TOTAL OF 45 LOTS WERE REWORKED FOR INCORRECTLY FOLDED INSTRUCTIONS FOR USE ( IFU) ( UNRELATED TO THE COMPLAINT ISSUE). IT APPEARS THAT A MIX-UP DURING THE REWORK OF THESE LOTS MAY HAVE OCCURRED. A REQUEST FOR CAPA (RFC) HAS BEEN INITIATED TO EVALUATE THE REWORK PROCESS IN QUESTION. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: A LONGER LABELED DEVICE IS LIKELY TO CAUSE OR CONTRIBUTE TO PT INJURY. DEVICE ISSUE: MISLABELED. IT WAS REPORTED THAT WHEN THE VISION STENT DELIVERY SYSTEM (SDS) PACKAGE WAS OPENED, IT WAS NOTICED THAT THE EXTERNAL PACKAGING WAS LABELED A 3.0X12MM, WHILE THE INTERNAL PRODUCT WAS A 3.0X23MM. THE DEVICE WAS NOT USED IN THE PT. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM 74MAF MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 7110732

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK