BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX II ASD OCCLUDER

    MDR report key: 19856449 · Received July 29, 2024

    Report

    Report Number
    3014616394-2024-00009
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    June 19, 2024
    Report Date
    September 6, 2024
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    PMA / PMN Number
    P200032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION: AN EVENT OF A DETACHED OCCLUDER WIRE WAS REPORTED. THE OCCLUDER WAS RECEIVED FOR ANALYSIS AND THE VISUAL INSPECTION CONFIRMED THE BROKEN WIRE. ONE WIRE WAS DETACHED FROM THE WELDED BALL/SEAM. NO OTHER DEVIATION WAS OBSERVED. FUNCTIONAL TESTING REVEALED NO DEVIATION. A DEVICE HISTORY REVIEW (DHR) REVEALED NO DEVIATIONS. THE DEVICE PASSED ALL VISUAL AND FUNCTIONAL TESTS AND MET ALL SPECIFICATIONS AT THE TIME OF PRODUCTION. PACKAGING AND SHIPPING WERE ACCORDING TO PROCESS. THE ENVIRONMENTAL CONDITIONS WERE WITHIN LIMITS DURING STORAGE. PER THE INSPECTION INSTRUCTIONS THE OCCLUDER WAS VISUALLY INSPECTED UNDER MICROSCOPE AT THE TIME OF PRODUCTION FOR ANY BROKEN WIRE. ANY FINDINGS WOULD HAVE BLOCKED THE OCCLUDER FROM RELEASE. PICTURES OF THE WELDED BALL OF THE OCCLUDER FROM LASER LAPTOP TAKEN DURING PRODUCTION WERE EXAMINED AND CONFIRMED THERE WERE NO DEVIATIONS AT THE TIME OF PRODUCTION. NO LOOSE WIRES, NO SCALING AND NO DEVIATION IN THE SHAPE AND POSITION OF THE WELDED SEAM WERE FOUND. PER THE PHYSICIAN THE CORRECT ACCESSORIES WERE USED TO LOAD THE OCCLUDER. IT IS POSSIBLE A WIRE COULD COME LOOSE FROM THE WELD SEAM IF TOO MUCH FORCE WAS APPLIED DURING LOADING. HOWEVER, THIS CANNOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION. BASED ON THE INVESTIGATIONAL RESULT, A PRODUCTION-RELATED ROOT CAUSE COULD NOT BE CONFIRMED. THE ROOT CAUSE OF THE EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE INTENDED IMPLANT OF THIS 18 MILLIMETER (MM) ATRIAL SEPTAL DEFECT (ASD) OCCLUDER, WHILE LOADING THE OCCLUDER THE PHYSICIAN OBSERVED THAT A SMALL WIRE OF THE OCCLUDER WAS DETACHED. A DIFFERENT OCCLUDER WAS USED AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2467428 FLEX II ASD OCCLUDER ASD OCCLUDER OZG OCCLUTECH GMBH 29ASD18

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Male