BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASHMERE 14 - CERECYTE MICROCOIL

    MDR report key: 4613584 · Received March 18, 2015

    Report

    Report Number
    2954740-2015-00077
    Event Type
    Malfunction
    Date Received
    March 18, 2015
    Date of Event
    March 4, 2015
    Report Date
    April 21, 2015
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K072173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT HAD SAH, ANEURYSM SIZE: 5 4.5MM. THE SURGEON ESTABLISHED ACCESS WITH 6F ENVOY GC AND PROWLER 14 MC. THE SURGEON POSITIONED THE 1ST COIL PRESIDIO 4 11.5 SUCCESSFULLY. AFTER OPENED THE PACKAGE OF THE 2ND CASHMERE COIL NOTED THAT IT HAD ALREADY PARTLY STRETCHED. THE SURGEON CHANGED DELTAPAQ 3 8 TO COMPLETE THE SURGERY. THERE WAS NO REPORT ON PATIENT SURGERY. THE PRODUCT WAS STORED PER LABELING INSTRUCTIONS, AND THERE WERE NO DAMAGE TO THE OUTER OR INNER PACKAGE. THE PRODUCT WAS REMOVED FROM THE PLASTIC HOOP PER LABELING INSTRUCTIONS, AND THERE WAS NOTHING THAT OCCURRED DURING REMOVAL FROM THE PLASTIC HOOP THAT CONTRIBUTED TO THE EVENT. THE PROCEDURE WAS FOR TREATMENT OF SAH. NO FURTHER INFORMATION WAS AVAILABLE. THE DELTAPAQ (LOT C21303) WILL NOT BE RETURNED, THEREFORE THE ROOT CAUSE OF THE COIL STRETCHING AND CRACKING CANNOT BE DETERMINED. 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 REPORTED EVENT WAS NOT CONFIRMED, SINCE THE CABLE PASSED ELECTRICAL CHECK. ADDITIONALLY, WITHOUT THE ENTIRE SYSTEMS INVOLVED IN THE EVENT, IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE EVENT. THE DHR 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. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS NOT CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, WITHOUT THE ENTIRE SYSTEMS INVOLVED IN THE EVENT, IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE EVENT. THE DHR 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. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE CASHMERE ((B)(4), LOT C21303) WILL NOT BE RETURNED; THEREFORE, THE ROOT CAUSE OF THE COIL FOUND TO BE STRETCHED AFTER OPENING THE PACKAGING CANNOT BE DETERMINED. 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. (B)(4). THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS, AND ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS RECEIVED FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE PATIENT HAD SAH, ANEURYSM SIZE: 5 X 4.5MM. THE SURGEON ESTABLISHED ACCESS WITH 6F ENVOY GC AND PROWLER 14 MC. THE SURGEON POSITIONED THE 1ST COIL PRESIDIO 4X11.5 SUCCESSFULLY. AFTER OPENED THE PACKAGE OF THE 2ND CASHMERE COIL NOTED THAT IT HAD ALREADY PARTLY STRETCHED. THE SURGEON CHANGED DELTAPAQ 3X8 TO COMPLETE THE SURGERY. THERE WAS NO REPORT ON PATIENT SURGERY. THE PRODUCT WAS STORED PER LABELING INSTRUCTIONS, AND THERE WERE NO DAMAGE TO THE OUTER OR INNER PACKAGE. THE PRODUCT WAS REMOVED FROM THE PLASTIC HOOP PER LABELING INSTRUCTIONS, AND THERE WAS NOTHING THAT OCCURRED DURING REMOVAL FROM THE PLASTIC HOOP THAT CONTRIBUTED TO THE EVENT. THE PROCEDURE WAS FOR TREATMENT OF SAH. NO FURTHER INFORMATION WAS AVAILABLE. THE PRODUCT WAS RECEIVED FOR ANALYSIS. LOCATED 45.0 CENTIMETERS OFF THE DISTAL TIP OF THE GREEN INTRODUCER, THE CORE WIRE AND COIL WERE FOUND PROTRUDING OUTSIDE THE SHEATH. LOCATED OFF THE DISTAL TIP OF THE GREEN INTRODUCER, THE BALL TIP HAS BEEN RETRACTED 36.5 CENTIMETERS. THE COIL WAS FOUND TO BE STRETCHED OUTSIDE THE PROTRUSION SITE OF THE SHEATH. THE COIL¿S SOCKET RING HAS COMPRESSED THE DISTAL TIP OF THE OUTER SHEATH. IN ADDITION IT WAS NOT REPORTED HOW A CLEAR LIQUID ENTERED INSIDE AND UNDER THE OUTER SHEATH SURROUNDING THE RESISTIVE HEATING COIL. IT WAS NOT REPORTED HOW DETACHED DEBRIS WITH A BLOOD-LIKE APPEARANCE WAS FOUND AT THE DISTAL SECTION OF THE COIL. MIDWAY ON THE COIL IS A COMPRESSION SECTION OF COIL INDICATING DISTAL INTERFERENCE OF AN UNKNOWN SOURCE. THE DISTAL SECTION OF THE COIL IS UNDAMAGED. NO MANUFACTURING DEFECTS WERE FOUND. THE CIRCUMSTANCES OF HOW AND WHEN THE COIL PROTRUDED AND STRETCHED OUTSIDE THE SHEATH UPON RECEIPT BY THE END USER CANNOT BE DETERMINED AS ALL COILS ARE ONE HUNDRED PERCENT INSPECTED PRIOR TO FINAL PACKAGING, FURTHERMORE DURING THE INSERTION PROCESS OF THE MICROCOIL SYSTEM INTO THE DISPENSER HOOP, A VISUAL INSPECTION WOULD HAVE EASILY CAUGHT THIS DAMAGED CONDITION. 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 REPORTED EVENT WAS CONFIRMED WITH ANALYSIS, AND THE CAUSE CANNOT BE DETERMINED. BASED ON THE INFORMATION AND CONDITION OF THE RETURNED DEVICE, IT APPEARS THAT APPEARS THAT PROCEDURAL OR PRODUCT HANDLING MAY HAVE CONTRIBUTED TO THE EVENT. THE DHR FOR THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD SAH, ANEURYSM SIZE: 5*4.5MM. THE SURGEON ESTABLISHED ACCESS WITH 6F ENVOY GC AND PROWLER 14 MC. THE SURGEON POSITIONED THE 1ST COIL PRESIDIO 4*11.5 SUCCESSFULLY. AFTER OPENED THE PACKAGE OF THE 2ND CASHMERE COIL NOTED THAT IT HAD ALREADY PARTLY STRETCHED. THE SURGEON CHANGED DELTAPAQ 3*8 TO COMPLETE THE SURGERY. THERE WAS NO REPORT ON PATIENT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183848 CASHMERE 14 - CERECYTE MICROCOIL CNV DCS COILS HCG CODMAN AND SHURTLEFF, INC C21303

    Patients

    Seq Age Sex Outcome Treatment
    1