BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS MULTI-LINK RX ULTRA CORONARY STENT SYSTEM

    MDR report key: 1790256 · Received August 6, 2010

    Report

    Report Number
    2024168-2010-01631
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    June 26, 2010
    Report Date
    June 28, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    P970020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED UNIT NOTED THAT THE RX ULTRA STENT DELIVERY SYSTEM (SDS) WAS IN THE DISPENSER COIL IN THE SEALED TYVEK POUCH. THE CHIPBOARD BOX WAS NOT RETURNED. ALL VENDOR AND MANUFACTURING SEALS WERE INTACT AND THERE WAS NO DAMAGE TO THE TYVEK POUCH. THE REGROOMING SHEATH WAS NOT PRESENT ON THE COMPLIANCE CHART OR INSIDE THE TYVEK POUCH, CONFIRMING THE REPORTED ISSUE NOTED IN REWORK. THERE WERE NO NON-CONFORMING MATERIAL RECORDS ISSUED DURING THE MANUFACTURE OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT AND THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED FOR THIS LOT. THE ROOT CAUSE OF THE MISSING REGROOMING SHEATH IS BEING INVESTIGATED BY MANUFACTURING. ALTHOUGH THE CHIPBOARD BOX WAS NOT RETURNED TO ABBOTT VASCULAR FOR EVALUATION, THE CHIPBOARD BOX WAS CONFIRMED TO BE DAMAGED WHEN RECEIVED IN REWORK. THE BOX MAY HAVE BEEN DAMAGED DURING SHIPPING, STORAGE AND/OR HANDLING ONCE IT LEFT THE ABBOTT VASCULAR DISTRIBUTION. HOWEVER, IT IS UNKNOWN HOW THE DAMAGE OCCURRED IN THIS CASE, BUT IT IS NOT BELIEVED TO BE A RESULT OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    DEVICE ISSUE: MISSING COMPONENTS. TIME OF DEVICE ISSUE: BEFORE PROCEDURE. ADVERSE EVENT: NONE. IT WAS REPORTED THAT THE UNIT WAS RETURNED FROM THE FIELD DUE TO A DAMAGE CHIPBOARD BOX. WHEN THE OPERATOR OPENED THE BOX, IT WAS NOTICED THAT THERE WAS A MISSING REGROOMING SHEATH. THIS IS BEING UPDATED TO A REPORTABLE EVENT BASED ON THE ROOT CAUSE IDENTIFYING A FAILURE OF THE DEVICE TO MEET THE SPECIFICATIONS ESTABLISHED IN THE APPROVAL PMA THAT COULD NOT CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY BUT ARE NOT CORRECTABLE BY ADJUSTMENTS OR OTHER MAINTENANCE PROCEDURES DESCRIBED IN THE APPROVAL LABELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS MULTI-LINK RX ULTRA CORONARY STENT SYSTEM MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 9061641

    Patients

    Seq Age Sex Outcome Treatment
    1 NA