BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH STEERABLE SHEATH

    MDR report key: 2211944 · Received August 15, 2011

    Report

    Report Number
    3002648230-2011-00129
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 17, 2011
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K081049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TWO FLEXCATH STEERABLE SHEATHS OF THE SAME LOT (06050) WERE RETURNED AND WERE VISUALLY INSPECTED AND FUNCTIONALLY TESTED. A 3FC12 LOT 06050, SERIAL NUMBER (B)(4), THE DEVICE PASSED THE INSPECTION AS PER SPECIFICATION. FOR 3FC12 LOT 06050, SERIAL NUMBER (B)(4), DISSECTION SHOWED THAT THE HEMOSTATIC VALVE WAS PARTIALLY DETACHED CAUSING A LEAK DURING THE RETRACTION PROCESS. A FIELD ACTION WAS INITIATED IN (B)(4) 2011 TO COMMUNICATE TO PHYSICIANS AND REGULATORY AUTHORITIES THE POTENTIAL LEAK IN HEMOSTATIC VALVE OF MEDTRONIC CRYOCATH FLEXCATH 12 STEERABLE SHEATHS.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. RESULTS OF EVALUATION OF RETURNED DEVICE WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING A CRYOABLATION PROCEDURE, THERE WAS A DIFFICULTY IN INSERTING THE ARCTIC FRONT CATHETER INTO THE FLEXCATH SHEATH, AND THE PHYSICIAN REMOVED THE SHEATH FROM THE PATIENT. AFTER REMOVAL OF THE SHEATH, THE PATIENT HAD ST ELEVATION AND PULMONARY ARREST. THE PATIENT HAD AN ANGIOGRAPHY AND THERE WERE NO COMPLICATIONS RESULTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXCATH STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 3FC12 06050

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Hospitalization| O