BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 5536577 · Received March 30, 2016

    Report

    Report Number
    3002648230-2016-00118
    Event Type
    Malfunction
    Date Received
    March 30, 2016
    Date of Event
    March 7, 2016
    Report Date
    May 24, 2016
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K123591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT SUMMARY: PATIENT DATA FILES SHOW AT LEAST TWENTY INJECTIONS WERE PERFORMED WITH NON-RETURNED CATHETER 2AF283 / 29921-63 WITHOUT ANY ISSUE. NO LOT NUMBER PROVIDED FOR PRODUCT 4FC12. IN CONCLUSION, THE REPORTED DETACHED STOPCOCK ISSUE CANNOT BE CONFIRMED. INVESTIGATION WAS UNABLE TO BE PERFORMED DUE TO NO PRODUCT RETURN.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A CRYO ABLATION PROCEDURE THE STOPCOCK DETACHED FROM THE SHEATH. THIS OCCURRED AT THE END OF THE PROCEDURE WHICH WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191086 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1