BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER DUCT OCCLUDER

    MDR report key: 8842975 · Received July 30, 2019

    Report

    Report Number
    2135147-2019-00216
    Event Type
    Injury
    Date Received
    July 30, 2019
    Date of Event
    June 28, 2019
    Report Date
    December 21, 2020
    Manufacturer
    ST. JUDE MEDICAL CATD
    Product Code
    MAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION SECTION: D2.

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION REGARDING THIS EVENT HAS BEEN REQUESTED. INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF ADVANCEMENT DIFFICULTY WHICH REPORTEDLY CAUSED A DEFORMATION UPON DEPLOYMENT COULD NOT BE CONFIRMED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS AT THE TIME OF COMMERCIALIZATION. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    ON (B)(6) 2019, AN 8MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT USING AN 8F TORQVUE DELIVERY SYSTEM (LOT #: 6834595). THE PHYSICIAN REPORTED INSERTION DIFFICULTY WHEN ADVANCING THE DEVICE THROUGH THE DELIVERY SYSTEM, CAUSING A DEFORMATION OF THE OCCLUDER UPON DEPLOYMENT. THE DEVICE WAS EXCHANGED FOR A 9MM AMPLATZER DUCT OCCLUDER (LOT #: 6172614) AND SUCCESSFULLY IMPLANTED USING A 9F TORQVUE DELIVERY SYSTEM (LOT #: 6525558). NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    ON (B)(6) 2019, A 14/12MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT USING AN 8F TORQVUE DELIVERY SYSTEM (LOT #: 6834595). THE PHYSICIAN REPORTED INSERTION DIFFICULTY WHEN ADVANCING THE DEVICE THROUGH THE DELIVERY SYSTEM, CAUSING A DEFORMATION OF THE OCCLUDER UPON DEPLOYMENT. THE DEVICE WAS EXCHANGED FOR A 16/14MM AMPLATZER DUCT OCCLUDER (LOT #: 6172614) AND SUCCESSFULLY IMPLANTED USING A 9F TORQVUE DELIVERY SYSTEM (LOT #: 6525558). NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637727 AMPLATZER DUCT OCCLUDER OCCLUDER, PATENT DUCTUS, ARTERIOSUS MAE ST. JUDE MEDICAL CATD 9-PDA-008 6883095

    Patients

    Seq Age Sex Outcome Treatment
    1