BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIT-OCCLUD PDA

    MDR report key: 8367488 · Received February 25, 2019

    Report

    Report Number
    3005704822-2019-00001
    Event Type
    Injury
    Date Received
    February 25, 2019
    Date of Event
    September 11, 2019
    Report Date
    November 21, 2019
    Manufacturer
    PFM MEDICAL MEPRO GMBH
    Product Code
    MAE
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) HAS BEEN REVIEWED AND SHOWED NO DEVIATIONS. THE INFORMATION PROVIDED BY THE USER WAS USED TO CONDUCT AN INVESTIGATION. THE FOLLOWING POINTS WERE EXAMINED DURING THE INVESTIGATION: DELIVERY CONDITION. COMPLETENESS. INVESTIGATION OF THE PRESENT PRODUCT REGARDING THE DESCRIBED ERROR CHARACTERISTIC FURTHER TESTS ON A DEFECT MODEL WITH A COIL OF THE SAME SIZE WERE PERFORMED TO SIMULATE THE DESCRIBED DEFECT FEATURE. THE DESCRIBED ERROR IMAGE COULD NOT BE RECREATED. IN SUMMARY, IT WAS FOUND THAT NO DEVIATIONS COULD BE DETECTED WHEN CHECKING DEVICE HISTORY RECORD AND THE PRODUCT ITSELF. THE PRODUCT CONFORMS TO THE SPECIFICATIONS.

    Description of Event or Problem · 0

    THE DEVICE DID NOT TAKE THE CORRECT FORM, SO IT WAS REMOVED TO REPOSITION. AT THE TIME OF REPOSITIONING, IT IS RELEASED INTO THE CORONARY ARTERY. IT WAS REMOVED WITH THE USE OF A MULTI-SNARE. DEVICE IS NOT MARKETED IN THE US BUT IS SIMILAR TO A US MARKETED DEVICE.

    Additional Manufacturer Narrative · 1

    THERE WAS NO EFFECT ON THE PATIENT. IT CANNOT BE EXCLUDED THAT A PRODUCT DEFECT EXISTS.

    Description of Event or Problem · 1

    THE PROXIMAL LOOP OF THE COIL WAS FRACTURED POSITIONING THE DEVICE ON THE DEFECT. THE DEVICE WAS PLACED ON THE DEFECT. IT WAS NOT NECESSARY TO REMOVE IT. REMOVING IT COULD HAVE LED TO COMPLICATIONS DUE TO THE DIMENSIONS OF THE PATIENT. THERE WAS A POTENTIAL RISK OF EMBOLIZATION. THIS EVEN OCCURED IN ARGENTINA USING A PRODUCT THAT IS SIMILARTO ONE MARKETED IN THE US (REF (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160776 NIT-OCCLUD PDA PDA OCCLUDER MAE PFM MEDICAL MEPRO GMBH 145076 1024081

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R