BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER TORQVUE DELIVERY SYSTEM

    MDR report key: 8842246 · Received July 30, 2019

    Report

    Report Number
    2135147-2019-00200
    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
    DQY
    PMA / PMN Number
    K072313
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF DEFORMED SHEATH TIP WAS CONFIRMED. GROSS MORPHOLOGICAL EXAMINATION REVEALED THE SHEATH TIP WAS INVERTED. 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 EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    REFERENCE MANUFACTURER REPORT NUMBER: (B)(4). 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 THE PARTIALLY RECAPTURED DEVICE WAS WITHDRAWN AND THE PROCEDURE WAS ABORTED.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

    THE REPORTED EVENT OF DIFFICULTY RETRACTING THE OCCLUDER AND DEFORMED SHEATH TIP 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 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. MDR-2019-30048.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636945 AMPLATZER TORQVUE DELIVERY SYSTEM CATHETER, PERCUTANEOUS DQY AGA MEDICAL CORPORATION 9-ITV07F45/80 6005920

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 9-ASD-011 BATCH # (B)(4).| AMPLATZER SEPTAL OCCLUDER.| 9-ASD-011 BATCH # (B)(4)