BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 3843844 · Received June 2, 2014

    Report

    Report Number
    3002648230-2014-00089
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K123591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. VISUAL INSPECTION SHOWED THE DEVICE WAS INTACT WITH NO APPARENT ISSUES. THE REPORTED AIR INGRESS DURING ASPIRATION ISSUE HAS BEEN CONFIRMED THROUGH TESTING; AIR ASPIRATION WAS REPRODUCED WHEN A TEST CATHETER WAS INTRODUCED THROUGH THE SHEATH. DISSECTION SHOWED THE HEMOSTATIC VALVE WAS LEAKING; VALVE WAS TORN. AN INTERNAL CAPA HAS BEEN INITIATED TO INVESTIGATE THE CONDITION FOUND. THIS REPORT WILL BE RECORDED AND TRENDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. 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.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THERE WAS AIR INGRESS DURING ASPIRATION OF THE SHEATH. THE ISSUE OCCURRED DURING PREPARATION OF THE SHEATH FOR A CRYOABLATION PROCEDURE, WHILE ATTEMPTING TO INSERT A CATHETER INTO THE SHEATH. AFTER 4 ATTEMPTS, THE PHYSICIAN REPLACED THE SHEATH, AND THERE WERE NO FURTHER ISSUES. THE CRYOABLATION PROCEDURE WAS COMPLETED USING THE REPLACEMENT SHEATH. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321673 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12 81510

    Patients

    Seq Age Sex Outcome Treatment
    1