BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH STEERABLE SHEATH

    MDR report key: 2974428 · Received February 22, 2013

    Report

    Report Number
    3002648230-2013-00031
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K081049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. VISUAL INSPECTION SHOWED THE SHAFT WAS KINKED AT 3.56 INCHES DISTAL FROM THE STRAIN RELIEF AND A DENT AT THE TIP. FUNCTIONAL TEST SHOWED THE DEFLECTION WORKED AS PER SPECIFICATION. THIS PRODUCT PROBLEM IS NOT BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT EXPERIENCED BY THE PATIENT. PERICARDIAL EFFUSION IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH CARDIAC CATHETER PROCEDURES.

    Description of Event or Problem · 1

    DURING A CRYOABLATION PROCEDURE, THE PHYSICIAN HAD SUCCESSFULLY ABATED THE LSPV TWO TIMES AND THE LIPV ONE TIME WHEN HE NOTICED A DROP IN THE PATIENT'S BLOOD PRESSURE TO 60/40S FOLLOWING THE THAW CYCLE OF THE BALLOON. THE PHYSICIAN MOVED THE INTRACARDIAC ULTRASOUND CATHETER AND DETERMINED THERE WAS AN EFFUSION. A PERICARDIALCENTISIS WAS PERFORMED AND THE PATIENT WAS STABLE. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY IN STABLE CONDITION. DEVICE 2 OF 3, REFERENCE MFR REPORTS: 3002648230-2013-00030 AND 3007798852-2013-00002

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78958 FLEXCATH STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 3FC12

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention ARCTIC FRONT 2AF282 & ACHIEVE (B)(4) CATHETERS