BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH STEERABLE SHEATH

    MDR report key: 3221252 · Received July 11, 2013

    Report

    Report Number
    3002648230-2013-00109
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    July 12, 2012
    Report Date
    April 23, 2013
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K081049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. VISUAL INSPECTION SHOWED THAT THE SHAFT WAS INTACT WITH NO APPARENT ISSUES. THE REPORTED AIR INGRESS COULD NOT BE REPRODUCED. MANY ASPIRATION / INJECTIONS WERE PERFORMED WITHOUT HAVING AIR BUBBLES OR LEAKS; THE HEMOSTATIC VALVE WAS LEAK TIGHT. THE SHEATH PASSED THE INSPECTION AS PER SPECIFICATION. THIS REPORT WILL BE RECORDED AND TRENDED. A FIELD ACTION WAS INITIATED IN JULY 2011 TO COMMUNICATE TO PHYSICIANS AND REGULATORY AUTHORITIES THE POTENTIAL LEAK IN THE HEMOSTATIC VALVE OF MEDTRONIC CRYOCATH FLEXCATH 12 STEERABLE SHEATHS, WHICH CAN RESULT IN AIR INGRESS DURING ASPIRATION. THE INITIAL DECISION FOR THIS EVENT WAS NOT MDR REPORTABLE SINCE THE SHEATH PASSED INSPECTION AS PER SPECIFICATION. DECISION CHANGED TO REPORTABLE FOLLOWING REVISION TO MEDTRONIC CRYOCATH REGULATORY REPORTING CRITERIA EFFECTIVE (B)(4) 2013.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THERE WAS AIR INGRESS DURING ASPIRATION OF THE SHEATH. THE SHEATH WAS REPLACED AND THE PROCEDURE CONTINUED. THE PATIENT WAS STABLE THROUGHOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320412 FLEXCATH STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 3FC12

    Patients

    Seq Age Sex Outcome Treatment
    1