BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK 8

    MDR report key: 3061944 · Received April 16, 2013

    Report

    Report Number
    2024168-2013-02329
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 22, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS RETURNED AND ANALYZED. THE REPORTED CATHETER SEPARATION WAS CONFIRMED ON THE RETURNED DEVICE AND MOST LIKELY RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE VISUAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, AFTER REMOVING A 4.0X18 RX MULTI-LINK 8 (ML8) STENT DELIVERY SYSTEM (SDS) FROM ITS DISPENSER HOOP WITHOUT ISSUE, WHILE PREPPING THE ML8, IT WAS NOTED THAT THE PROXIMAL SHAFT SNAPPED (SEPARATED) CLOSE TO THE HUB AREA. THERE WAS NO PATIENT INVOLVEMENT AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163357 MULTI-LINK 8 CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2091441

    Patients

    Seq Age Sex Outcome Treatment
    1