BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH STEERABLE SHEATH

    MDR report key: 2892114 · Received January 2, 2013

    Report

    Report Number
    3002648230-2013-00002
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K081049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THERE WAS NO INDICATION OF PRODUCT MALFUNCTION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AFTER TRANSSEPTAL PUNCTURE, THE SHEATH WAS BROUGHT INTO THE LEFT SIDE OF THE HEART. THE CRYOABLATION CATHETER AND MAPPING CATHETER WERE INSERTED THROUGH THE SHEATH, AND THE CRYOBALLOON WAS INFLATED. WHEN CONTRAST WAS INJECTED ANATOMY DID NOT LOOK LIKE VEIN. THE CRYOBALLOON WAS DEFLATED, CATHETERS REPOSITIONED INTO LSPV, AND CRYOBALLOON WAS REINFLATED. CONTRAST WAS INJECTED AND IDENTIFIED A GOOD BALLOON OCCLUSION. AS CRYO APPLICATION STARTED, THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP. UTILIZING ICE, THE PHYSICIAN IDENTIFIED PERFORATION IN VENTRICLE. ABLATION WAS STOPPED AT 237 SECONDS AT -57 DEGREES. PHYSICIANS UTILIZED PERICARDIOCENTESIS KIT AND REMOVED FLUID AND PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1518 FLEXCATH STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 3FC12 36603

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention ARCTIC FRONT ADVANCE (B)(4), ACHIEVE (B)(4)