BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 8840866 · Received July 30, 2019

    Report

    Report Number
    2135147-2019-00203
    Event Type
    Malfunction
    Date Received
    July 30, 2019
    Date of Event
    June 26, 2019
    Report Date
    November 13, 2020
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF DIFFICULTY RETRACTING THE DEVICE WAS REPORTED. THE INVESTIGATION CONFIRMED THE DEVICE MET FUNCTIONAL AND DIMENSIONAL SPECIFICATIONS WHEN ANALYZED AT ABBOTT. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    REFERENCE MANUFACTURER REPORT NUMBER: 2135147-2019-00200. ON (B)(6) 2019, A 13MM AMPLATZER SEPTAL OCCLUDER (LOT NUMBER: 6867152) WAS SELECTED FOR IMPLANT USING A 45/80MM 7F TORQVUE DELIVERY SYSTEM IN A 10KG CHILD. THE DEVICE WAS MIS-SIZED, TOO LARGE, AND EXCHANGED FOR AN 11MM AMPLATZER SEPTAL OCCLUDER (LOT NUMBER: 6851795). DURING IMPLANT, THE SECOND DEVICE WAS UNABLE TO BE PLACED DURING THE FIRST PASS. SUBSEQUENTLY THE PHYSICIAN EXPERIENCED DIFFICULTY RESHEATHING THE DEVICE, ONLY MANAGING TO HALF SHEATH THE DEVICE USING GREAT FORCE. THE PARTIALLY RECAPTURED DEVICE WAS WITHDRAWN AND THE PROCEDURE WAS ABORTED. THE TIP OF THE DELIVERY SYSTEM WAS OBSERVED TO HAVE DEFORMED IN A CONCERTINA AFTER REMOVAL FROM THE PATIENT. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS REFERRED FOR SURGICAL CLOSURE. NO PATIENT CONSEQUENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION REGARDING THIS EVENT HAS BEEN REQUESTED. THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Additional Manufacturer Narrative · 1

    09/13/2019 MJR ¿ SUPPLEMENTAL REPORT NEEDED TO ADDRESS ANALYSIS: THE REPORTED EVENT OF DIFFICULTY RE-SHEATHING THE DEVICE 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, A 13MM AMPLATZER SEPTAL OCCLUDER (LOT NUMBER: 6867152) WAS SELECTED FOR IMPLANT USING A 45/80MM 7F TORQUE DELIVERY SYSTEM IN A 10KG CHILD. THE DEVICE WAS MIS-SIZED, TOO LARGE, AND EXCHANGED FOR AN 11MM AMPLATZER SEPTAL OCCLUDER (LOT NUMBER: 6851795). DURING IMPLANT, THE SECOND DEVICE WAS UNABLE TO BE PLACED DURING THE FIRST PASS. SUBSEQUENTLY THE PHYSICIAN EXPERIENCED DIFFICULTY RESHEATHING THE DEVICE, ONLY MANAGING TO HALF SHEATH THE DEVICE USING GREAT FORCE. THE PARTIALLY RECAPTURED DEVICE WAS WITHDRAWN AND THE PROCEDURE WAS ABORTED. THE TIP OF THE DELIVERY SYSTEM WAS OBSERVED TO HAVE DEFORMED IN A CONCERTINA AFTER REMOVAL FROM THE PATIENT. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS REFERRED FOR SURGICAL CLOSURE. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635270 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV AGA MEDICAL CORPORATION 9-ASD-011 6851795

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R AMPLATZER TORQVUE DELIVERY SYSTEM