BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIT-OCCLUD PDA

    MDR report key: 8316341 · Received February 7, 2019

    Report

    Report Number
    3005704822-2018-00001
    Event Type
    Malfunction
    Date Received
    February 7, 2019
    Date of Event
    January 1, 2018
    Report Date
    February 7, 2019
    Manufacturer
    PFM MEDICAL MEPRO GMBH
    Product Code
    MAE
    UDI-DI
    04042301160034
    PMA / PMN Number
    P120009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS PROVIDED AND WAS USED TO CONDUCT AN INVESTIGATION. THE DEVICE HISTORY RECORD (DHR) HAS BEEN REVIEWED AND SHOWED NO DEVIATIONS. THE COIL, ITEM 145116, WAS STILL MOUNTED ON THE CARRIER AND WITH THE PROXIMAL PART STILL IN THE TRANSPORTATION SHEATH. THE CATHETER WAS CONTAMINATED WITH BLOOD AND NO LONGER USABLE. IF THE CATHETER HAS NOT BEEN FLUSHED ENOUGH DURING IMPLANTATION, A GRAFT MAY FORM WHICH THEN MAKES THE REASON FOR THE COMPLAINT PLAUSIBLE. TO RECONSTRUCT THE REASON FOR THE COMPLAINT, A NEW IMPLANTATION CATHETER WAS USED. THE COIL COULD BE EASILY PUSHED THROUGH THE CATHETER, CONFIGURED, AND WITHDRAWN WITHOUT PROBLEMS. NO FURTHER SIMILAR COMPLAINTS WERE REPORTED TO MEPRO IN THE PAST. BASED ON PREVIOUS EXPERIENCE, INSUFFICIENT RINSING CANNOT BE RULED OUT. THE COMPLAINT IS NOT JUSTIFIED.

    Description of Event or Problem · 1

    THE COIL WENT OUT OF THE TRANSPORTATION SHEATH. DOCTOR'S REPORT: "AFTER INTRODUCING THE COIL, WE TRIED TO REPOSITION IT. AT THE FIRST TRIAL OF REPOSITION THE LOOPS STUCKED ON THE CATHETER AND REFUSED TO GO BACK INSIDE THE CATHETER OR REFIGURED AGAIN AT ALL. AFTER FLUSHING THE SYSTEM SEVERAL TIMES, WE TRIED TO PULL IT HARDER TO LET IT MOVE, THEN IT'S WENT OUT OF THE TRANSPORTATION SHEATH." COULD RESULT IN EMBOLISM OF THE DEVICE IS OCCURRED AGAIN REQUIRED INTERVENTION TO REMOVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112120 NIT-OCCLUD PDA PDA OCCLUDER MAE PFM MEDICAL MEPRO GMBH 145116 1021317 04042301160034

    Patients

    Seq Age Sex Outcome Treatment
    1 Other