BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMEGA¿

    MDR report key: 3051272 · Received April 10, 2013

    Report

    Report Number
    2134265-2013-02244
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    February 4, 2013
    Report Date
    March 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE OMEGA CATHETER WAS RECEIVED INSIDE A CARRIER TUBE (HOOP). THE TIP WAS STRETCHED. THE PROXIMAL AND DISTAL ENDS OF THE STENT WERE PARTIALLY DEPLOYED, WHICH INDICATES THE BALLOON WAS SUBJECTED TO POSITIVE (INFLATION PRESSURE). THE DEVICE PRESENTED NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED (B)(6) 2013. IT WAS REPORTED THAT PRIOR TO A STENTING TREATMENT PROCEDURE, THE SHAFT WAS DAMAGED. AS THE 2.5X20MM OMEGA STENT WAS PULLED FROM INVENTORY IT WAS NOTED THAT THE CATHETER SHAFT WAS CRUSHED. AS THERE WAS NO CONTACT WITH THE PATIENT, NO COMPLICATIONS WERE REPORTED; HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE STENT WAS PARTIALLY DEPLOYED. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148429 OMEGA¿ STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493913820250 14376870

    Patients

    Seq Age Sex Outcome Treatment
    1