BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT MICROCATHETERS

    MDR report key: 4103166 · Received September 19, 2014

    Report

    Report Number
    1058196-2014-00231
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 28, 2014
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    KRA
    PMA / PMN Number
    K021591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION, THE EVENT COULD NOT BE CONFIRMED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. HOWEVER SINCE THERE IS NO EVIDENCE OF A MANUFACTURING ISSUE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE ISSUE. THERE WAS NO RESISTANCE FELT THROUGH THE HEADWAY 17 MICROCATHETER OR PROWLER SELECT PLUS MICROCATHETER. NO KINKS OR BENDS ON ANY OF THE PRODUCTS WERE REPORTED. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER. THERE WAS NO DIFFICULTY TRACKING THE CATHETER TO THE TARGET SITE OR EXCESSIVE MANIPULATION/TORQUING REQUIRED PRIOR TO INTRODUCTION OF THE DEVICE. CATALOG NUMBER 606S255X FOR THE PROWLER SELECT PLUS WAS OBTAINED. THIS IS REPORT 2 OF 2 RELATED TO COMPLAINT #(B)(4). SUSPECT MEDICAL DEVICES, THE ENTERPRISE STENT (ENC452812/10367366) SHOULD HAVE BEEN PROVIDED IN PLACE OF THE PROWLER SELECT PLUS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS AND ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING STENT-ASSISTED EMBOLIZATION OF A POSTERIOR COMMUNICATING ARTERY (5X7 MM) FRICTION WAS FELT IN THE MICROCATHETER AND THE ENTERPRISE STENT (ENC452812/10367366) COULD NOT BE ADVANCED INTO THE MICROCATHETER. THE SURGEON PUT A 6F ENVOY (DETAILS UNKNOWN) TO ESTABLISH ACCESS AND PROWLER SELECT PLUS (DETAILS UNKNOWN) IN PLACE. THE OTHER MICROCATHETER USED WAS HEADWAY 17 FROM MICROVENTION (DETAILS UNKNOWN). TWO COILS HAD BEEN POSITIONED SMOOTHLY. THE SURGEON FELT FRICTION AND THE STENT COULD NOT BE ADVANCED INTO THE MICROCATHETER. THE SURGEON TRIED TO WITHDRAW THE STENT BUT STILL FAILED. FINALLY THE SURGEON REMOVED THEM AS A UNIT AND CHANGED ANOTHER STENT TO COMPLETE. NO ADVERSE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581571 PROWLER SELECT MICROCATHETERS CES MICROCATHETERS (KRA) KRA CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR