BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASHMERE 14 - CERECYTE MICROCOIL

    MDR report key: 4250048 · Received November 14, 2014

    Report

    Report Number
    2954740-2014-50035
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 23, 2014
    Report Date
    October 23, 2014
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K072173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: SINCE IT HAS ALREADY BEEN DISPOSED, THE COIL IS NOT AVAILABLE FOR THE INVESTIGATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE COMPLAINT COULD NOT BE CONFIRMED WITHOUT PRODUCT RETURN FOR ANALYSIS. IN ADDITION, THE ROOT CAUSE COULD NOT BE CONFIRMED. SINCE THE PROCEDURE WAS COMPLETED WITH THE SAME COIL AND DETACHMENT CONTROL BOX, THESE DEVICES WERE NOT RELATED TO THE EVENT. BASED ON THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING ISSUE; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS AN INITIAL/FINAL MDR.

    Description of Event or Problem · 1

    DURING VRD-ASSISTED COIL EMBOLIZATION OF AN ANEURYSM IN THE PATIENT¿S ABDOMINAL AORTA, THE PHYSICIAN WAS UNABLE TO DETACH THE CASHMERE COIL (B)(4) AFTER 5 ATTEMPTS. THE COIL WAS REPLACED WITH ANOTHER COIL FROM A DIFFERENT LOT. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES OR DELAY, AND THERE WERE NO PATIENT INJURY/COMPLICATIONS. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH HAD BEEN MAINTAINED THROUGH THE PROWLER SELECT PLUS MICROCATHETER AT ALL TIMES. PRIOR TO USE, NO DEFECT (KINK, BENDS, ETC.) WAS NOTED ON THE PRODUCT BY VISUAL INSPECTION. ALSO NO DAMAGES WERE REPORTED ON THE DEVICES AFTER THE EVENT. SINCE IT HAS ALREADY BEEN DISPOSED, THE COIL IS NOT AVAILABLE FOR THE INVESTIGATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736979 CASHMERE 14 - CERECYTE MICROCOIL CNV DCS COILS HCG CODMAN AND SHURTLEFF, INC CRC14123030 C19140

    Patients

    Seq Age Sex Outcome Treatment
    1 PROWLER SELECT PLUS MICROCATHETER