BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH STEERABLE SHEATH

    MDR report key: 2240671 · Received September 9, 2011

    Report

    Report Number
    3002648230-2011-00156
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 10, 2011
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K081049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED FLEXCATH STEERABLE SHEATH 3FC12 SERIAL # (B)(4) WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED AND PASSED THE INSPECTION AS PER SPECIFICATION. THE INSPECTION SHOWED THAT THE SHAFT WAS INTACT WITH NO APPARENT ISSUES AND THE REPORTED AIR INGRESS DURING ASPIRATION COULD NOT BE REPRODUCED. MANY ASPIRATION / INJECTIONS WERE PERFORMED WITHOUT HAVING AIR BUBBLES OR LEAKING THROUGH THE HEMOSTATIC VALVE OF THE FLEXCATH STEERABLE SHEATH. TWO ARCTIC FRONT CATHETERS (2AF282) WERE ALSO RETURNED FOR INVESTIGATION AND BOTH PASSED THE VISUAL AND FUNCTIONAL INSPECTIONS AS PER SPECIFICATION. ALTHOUGH THE REPORTED ISSUE COULD NOT BE REPRODUCED WITH FLEXCATH STEERABLE SHEATH 3FC12 SERIAL # (B)(4), THIS IS A KNOWN ISSUE FOR THE FLEXCATH STEERABLE SHEATH AND IS LINKED TO A LEAKING HEMOSTATIC VALVE. A FIELD ACTION WAS INITIATED IN (B)(4) 2011 TO COMMUNICATE TO PHYSICIANS AND REGULATORY AUTHORITIES THE POTENTIAL LEAK IN HEMOSTATIC VALVE OF MEDTRONIC CRYOCATH FLEXCATH 12 STEERABLE SHEATHS.

    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

    DURING A CRYOABLATION PROCEDURE, THE ARCTIC FRONT CATHETER WAS INSERTED INTO THE FLEXCATH STEERABLE SHEATH. DURING ASPIRATION, AIR WAS PRESENT IN THE FLEXCATH STEERABLE SHEATH. THE ARCTIC FRONT CATHETER WAS REPLACED BY ANOTHER ARCTIC FRONT CATHETER AND THE SHEATH WAS ASPIRATED AND FLUSHED WITHOUT ANY DIFFICULTY. THE CASE WAS COMPLETED WITHOUT ANY COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXCATH STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 3FC12 36911

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCTIC FRONT CATHETER 2AF282