BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROWLER SELECT MICROCATHETERS

    MDR report key: 3843554 · Received June 2, 2014

    Report

    Report Number
    1058196-2014-00161
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 12, 2014
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    KRA
    PMA / PMN Number
    K021591
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS, AND ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS REPORT 2 OF 3 RELATED TO (B)(4).

    Additional Manufacturer Narrative · 1

    VESSEL PERFORATION IS A KNOWN PROCEDURAL COMPLICATION FOR THE ENTERPRISE STENT AND THE PROWLER MICROCATHETER AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. BASED ON THE PHOTOS RECEIVED AND THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO CONFIRM IF THESE DEVICES CONTRIBUTED TO THE VESSEL DAMAGE. ALSO, WITHOUT PRODUCT RETURN OR FULL PROCEDURAL FILMS, IT IS NOT POSSIBLE TO CONFIRM STENT MARKER DAMAGE OR THE REPORT OF POSSIBLE LONGER STENT MARKER. IN ADDITION, AN OVERSIZED MARKER WOULD CAUSE ADDITIONAL FRICTION THAT WOULD RESULT IN DIFFICULTY LOADING IT ONTO THE WIRE. BASED ON THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE SUSPECTED STENT DAMAGE REPORTED BY THE CUSTOMER OR FACTORS THAT MAY HAVE CONTRIBUTED TO THE DAMAGE. INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED DEVICES FROM LEAVING THE MANUFACTURING FACILITY. THERE IS NO EVIDENCE PROVIDED IN THE PHOTOS OR THE REPORTED COMPLAINT THAT THERE WAS A MANUFACTURING ISSUE RELATED TO THIS COMPLAINT. IN ADDITION REVIEW OF LOT 15936317 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION BASED ON REVIEW OF IMAGES (6/4/2014): FOUR IMAGES WERE RECEIVED, INCLUDING A BASELINE ANGIOGRAPHY OF A MCA ANEURYSM, IMAGE WITH A COIL IN THE ANEURYSM, ENTERPRISE DELIVERY WIRE IN THE M2 WITH EXTRAVASATION SEEN AT THE BIFURCATION AREA, IMAGE WITH ENTERPRISE DELIVERY WIRE IN PLACE & ARROW INDICATING PRESENCE OF REPORTED EXTRAVASCULAR DISTAL MARKER OF THE ENTERPRISE. BASED ON THE IMAGES, THERE IS NO INDICATION THAT THE PROWLER 14 CONTRIBUTED TO THE VESSEL DAMAGE. CONCLUSIONS WILL BE FORTHCOMING FOR THIS COMPLAINT.

    Description of Event or Problem · 1

    AFTER THE SURGEON POSITIONED ONE UNDETACHED COIL (DETAILS UNKNOWN) IN THE ANEURYSM THEN DEPLOYED AN ENTERPRISE 14 ((B)(4)/LOT UNKNOWN) RADIOGRAPHY INDICATED THAT BLOOD LEAKED FROM THE ARTERY BIFURCATION AND HEMATOMA OCCURRED THREE DAYS AFTER SURGERY. THE PROWLER 14 MICROCATHETER (DETAILS UNKNOWN) AND THE PROWLER SELECT PLUS MICROCATHETER ((B)(4)) WERE USED IN THE PROCEDURE. THE PROWLER 14 MICROCATHETER WAS PLACED IN THE ANEURYSM AND THE PROWLER SELECT PLUS WAS PLACED IN THE RIGHT M2 SECTION OF THE MIDDLE CEREBRAL ARTERY. THE SURGEON SUSPECTED THAT THE VESSEL WAS ¿PRICKED¿ BY THE MARKER ON THE STENT. THE SURGEON ALSO NOTED THAT THE MARKER SEEMED TO BE LONGER THAN OTHER MARKERS AND ALSO SUSPECTED WHETHER THE MARKER WAS BROKEN. THE PATIENT IS IN STABLE CONDITION AT THE TIME OF THE COMPLAINT. THE SALES REP CONFIRMED THAT THE STENT WAS ADVANCED WITHOUT ANY FRICTION AND THE PHYSICIAN OPERATED IN ¿GOOD PRACTICE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322380 PROWLER SELECT MICROCATHETERS CES MICROCATHETERS (KRA) KRA CORDIS NEUROVASCULAR, INC. NA 15936317

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening