BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 3772341 · Received April 25, 2014

    Report

    Report Number
    3002648230-2014-00074
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K123591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. VISUAL INSPECTION SHOWED THE SHAFT WAS INTACT WITH NO APPARENT ISSUES. THE REPORTED AIR INGRESS COULD NOT BE REPRODUCED; THE DEVICE PASSED THE RETURNED PRODUCT INSPECTION AS PER SPECIFICATION. MULTIPLE ASPIRATIONS / INJECTIONS WERE PERFORMED WITHOUT AIR BUBBLES OR LEAKS; HEMOSTATIC VALVE AND VALVE ASSEMBLY WERE LEAK TIGHT. THIS REPORT WILL BE RECORDED AND TRENDED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THERE WAS AIR INGRESS DURING ASPIRATION WHILE A GUIDE WIRE WAS INSERTED THROUGH THE SHEATH. THE SHEATH WAS REPLACED AND THE CRYOABLATION PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252631 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12

    Patients

    Seq Age Sex Outcome Treatment
    1