BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIT-OCCLUD PDA

    MDR report key: 8316344 · Received February 7, 2019

    Report

    Report Number
    3005704822-2018-00002
    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
    04042301160010
    PMA / PMN Number
    P120009
    Adverse Event
    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 145096, WAS SEVERELY DEFOM1ED PROXIMALLY. DEFORMATIONS OF THIS KIND OFTEN OCCUR WHEN A COIL NEEDS TO BE RETRIEVED USING A SLING. THE SECURING CLIP ON THE HANDLE HAD NOT BEEN PULLED YET. BASED ON THE USER STATEMENTS, THE DESCRIBED ERROR FEATURE CANNOT BE RECONSTRUCTED. THE SYSTEMS ARE PUSHED 100% THROUGH THE ENCLOSED CATHETER DURING THE TEST IN PRODUCTION. 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 WAS RELEASED INSIDE THE PATIENT. DOCTOR'S REPORT: "WE TRIED WITH A COIL AND DURING CONFIGURATION OF THE LAST TWO LOOPS, IS STUCK IN THE CATHETER REFUSING TO GET OUT OR TO GET BACK IN THE CATHETER WE TRIED A LOT UNTIL IT'S RELEASED IN IMPROPER POSITION WHICH FORCE TO SNARE IT AND SEND THE PATIENT TO SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108782 NIT-OCCLUD PDA PDA OCCLUDER MAE PFM MEDICAL MEPRO GMBH 145096 1018320 04042301160010

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention