BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIT-OCCLUD PDA

    MDR report key: 16495516 · Received March 7, 2023

    Report

    Report Number
    3005704822-2023-00001
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    November 9, 2022
    Report Date
    March 7, 2023
    Manufacturer
    PFM MEDICAL MEPRO GMBH
    Product Code
    MAE
    PMA / PMN Number
    P120009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS FORWARDED TO THE MANUFACTURER AND INVESTIGATED. THE DEVICE HISTORY RECORD (DHR) HAS BEEN REVIEWED AND SHOWED NO DEVIATIONS. THE INFORMATION PROVIDED WAS USED TO CONDUCT AN INVESTIGATION. DURING THE INVESTIGATION, SEVERE DEFORMATIONS WERE FOUND ON THE PUSHER UNIT AND THE COIL. AFTER CONSULTATION, THE DEFORMATION ON THE PUSHER UNIT WAS EXPLAINED BY CLEANING IT BY THE HOSPITAL STAFF AND THUS OCCURRED AFTER USE. THE DEFORMATION ON THE COIL COULD BE EXPLAINED WITH THE DESCRIBED RECOVERY WITH THE SNARE. FURTHERMORE, DURING THE INSPECTION THE COIL COULD BE SCREWED TO THE CARRIER SYSTEM AGAIN AND SHOWED NO ABNORMALITIES. NO CAUSE COULD BE FOUND WHY THE COIL SPONTANEOUSLY RELEASES EARLY.

    Description of Event or Problem · 0

    PEDIATRIC PATIENT IS ADMITTED FOR PERCUTANEOUS PDA CLOSURE. AN ADDITIONAL PROCEDURE IS REQUIRED TO RESCUE THE COIL DEVICE, WHICH RELEASED SPONTANEOUSLY AND UNCONTROLLED. THE PATIENT DIAGNOSED WITH PDA WAS TREATED BY DR. (B)(6). SHE CHOOSES A NIT-OCCLUD COIL 6X5. WHEN SHE WAS PREPARING THE DEVICE, IT PRESENTED RESISTANCE WHEN ADVANCING IT THROUGH THE SHEATH, (INCLUDED WITH THE DEVICE). AT THE TIME WHEN THE DEVICE IS POSITIONED IN PLACE, (AT PDA), THE DEVICE SPONTANEOUSLY RELEASES, AND IT IS REQUIRED TO RESCUE, (SNARE), THE DEVICE. THE COIL 6X5 IS RECOVERED WITH A SNARE. A PDA 7X6 WAS IMPLANTED WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139804 NIT-OCCLUD PDA OCCLUDER, PATENT DUCTUS, ARTERIOSUS MAE PFM MEDICAL MEPRO GMBH 145065V1 1035001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention