BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH STEERABLE SHEATH

    MDR report key: 2862872 · Received December 10, 2012

    Report

    Report Number
    3002648230-2012-00119
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    October 24, 2012
    Report Date
    November 9, 2012
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K081049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THE ALLEGED FAILURE WAS NOT POSSIBLE SINCE THE DEVICE WAS NOT RETURNED; IT WAS DISCARDED BY THE USER FACILITY. A FIELD ACTION WAS INITIATED IN (B)(4) 2011 TO COMMUNICATE TO PHYSICIANS AND REGULATORY AUTHORITIES THIS POTENTIAL LEAK IN HEMOSTATIC VALVE OF MEDTRONIC CRYOCATH FLEXCATH 12 STEERABLE SHEATHS. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE SHEATH HAD A LEAKING HEMOSTATIC VALVE. THE PATIENT EXPERIENCED AIR EMBOLISM, BUT RECOVERED AT THE END OF THE PROCEDURE. ST ELEVATION WAS SEEN AT THE ECG DURING PROCEDURE WHILE APPROACHING THE LIPV. THE PHYSICIAN WAITED, AND THE PATIENT RECOVERED IMMEDIATELY. PATIENT WITHOUT PROBLEMS AFTER COMPLETING THE CRYOABLATION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXCATH STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 3FC12 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Other