BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 4243371 · Received November 11, 2014

    Report

    Report Number
    3002648230-2014-00193
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 16, 2014
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K123591
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION; IT WAS DISCARDED AFTER THE PROCEDURE. THERE WAS NO INDICATION OF PRODUCT MALFUNCTION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION OF A LEFT FEMORAL ARTERY PSEUDOANEURYSM. CRYOABLATION PROCEDURE WAS PERFORMED ON (B)(6) 2014. FOLLOWING SHEATH REMOVAL, THE PATIENT DEVELOPED PAINFUL LEFT GROIN HEMATOMA. THE FOLLOWING DAY A BRUIT WAS HEARD. AN ULTRASOUND WAS PERFORMED WHICH SHOWED A 7.5 X 2.5 X 3 CM ARTERIALIZED VASCULAR COLLECTION CONNECTED BY A 3MM X 2CM STALK CONSISTENT WITH A PSEUDOANEURYSM. PERCUTANEOUS THROMBOSIS OF CAVITY WAS PERFORMED ON (B)(6) 2014. EVENT RESULTED IN PROLONGATION OF PATIENT'S HOSPITALIZATION. EVENT RESOLVED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725583 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization