BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRUSPHERE 18 - CERECYTE MICROCOIL

    MDR report key: 4550958 · Received February 26, 2015

    Report

    Report Number
    2954740-2015-00064
    Event Type
    Malfunction
    Date Received
    February 26, 2015
    Date of Event
    February 4, 2015
    Report Date
    February 5, 2015
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K033813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY THE HOSPITAL THAT THE PHYSICIAN SUCCESSFULLY PLACED THE COIL (CSP18050030/C27689) THROUGH AN SL-10 MICROCATHETER (DETAILS UNKNOWN) INTO AN ACOM ANEURYSM. WHEN HE TRIED TO DETACH THE COIL IT WOULD NOT DETACH. SEVERAL ATTEMPTS WERE MADE TO DETACH, BUT WERE NOT SUCCESSFUL. THE COIL WILL BE RETURNED FOR ANALYSIS. PATIENT DEATH OR SERIOUS INJURY DID NOT OCCUR AS A RESULT OF THE EVENT. ADDITIONAL MEDICAL INTERVENTION OR MEDICATION WAS NOT REQUIRED TO PREVENT IMPAIRMENT OR INJURY. THERE WERE NO DAMAGES NOTED ON THE COIL AFTER USE. THE SAME MICROCATHETER, DETACHMENT CONTROL BOX (DETAILS UNKNOWN), AND CONNECTING CABLE (DETAILS UNKNOWN) WERE USED TO COMPLETE THE PROCEDURE. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE LOW BATTERY LIGHT WAS SEEN DURING THE CASE. THE FAULT LIGHT WAS NOT SEEN DURING THE CASE. THE GREEN SYSTEM READY LIGHT ILLUMINATED. DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT ILLUMINATED. THE AUDIBLE SIGNAL BEEPED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THERE WAS NO RESISTANCE DURING DEPLOYMENT OF THE COIL SYSTEM THROUGH THE MICROCATHETER. TORQUING OF THE DPU WAS NOT REQUIRED DURING POSITIONING OF THE COIL IN THE ANEURYSM. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE EVENT. UPON RECEIPT, THE DEVICE POSITIONING UNIT (DPU) PASSED ELECTRICAL TESTING WITH RESISTANCE AT 52.3 OHMS AND THE ENPOWER SYSTEMS GO GREEN LIGHT ILLUMINATED. THE COIL DETACHED ON THE FIRST DETACHMENT CYCLE. POST-DETACHMENT RESISTANCE PASSES WITH A READING OF 52.3 OHMS. AFTER LABORATORY COIL DETACHMENT IT WAS FOUND THAT THE DETACHMENT FIBER RECEIVED HEAT AND MELTED AS DESIGNED. NO MANUFACTURING DEFECTS WERE FOUND. LABORATORY TESTING COULD NOT DUPLICATE THE FIELD COMPLAINT; THEREFORE THE ROOT CAUSE OF THE COILS NON-DETACHMENT CANNOT BE DETERMINED. IN ADDITION, WITHOUT THE RETURN OF THE COMPLETE DETACHMENT SYSTEM, THE SEVERED PULL TAB SECTION OF THE SHEATH, AND THE SL-10 MICROCATHETER USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS CONTRIBUTE D TO THE COMPLAINT EVENT. ADDITIONAL NARRATIVE COMPLAINT RELATED: IT WAS NOT REPORTED IF OR WHEN THE DCB WITH THE LOW BATTERY LIGHT WAS REPLACED WITH A FULLY CHARGED DCB TO CONTINUE THE PRE-DEPLOYMENT ELECTRICAL CHECK OR PROCEDURE. IT IS HIGHLY RECOMMENDED THAT THE DCB WITH THE LOW BATTERY LIGHT ILLUMINATING SHOULD BE RETURNED FOR REPLACEMENT. FOR OPTIMUM PRODUCT PERFORMANCE AND TO PREVENT POTENTIAL COMPLICATIONS, THE INSTRUCTIONS FOR USE (IFU) RECOMMENDS, ¿NOTE: THIS DCB CONTAINS NO USER REPLACEABLE BATTERIES. PRESS THE POWER BUTTON ON THE FRONT PANEL OF THE DCB. ALL INDICATOR LIGHTS WILL ILLUMINATE BRIEFLY THEN TURN OFF WHILE THE UNIT PERFORMS A SELF-TEST. WITH NO CABLES CONNECTED, ONLY ONE OF THE BATTERY INDICATOR LIGHTS SHOULD BE ILLUMINATED. IF THE GREEN FULL BATTERY LIGHT IS ILLUMINATED, THE DCB IS FUNCTIONING PROPERLY. IF THE AMBER LOW BATTERY LIGHT IS ILLUMINATED, THEN THE DCB WILL FUNCTION PROPERLY, BUT LESS THAN 100 DETACH CYCLES REMAIN ON THE UNIT. IF THE RED DEAD BATTERY LIGHT IS ILLUMINATED, THE DCB WILL NOT FUNCTION. REPLACE WITH NEW DCB. IF THE RED SYSTEM FAULT LIGHT, OR NO LIGHT, IS ILLUMINATED, THEN THE DCB IS NOT FUNCTIONING PROPERLY. THE UNIT SHOULD NOT BE USED AND SHOULD BE RETURNED TO CODMAN ENDOVASCULAR OR AN AUTHORIZED REPRESENTATIVE FOR REPLACEMENT. ADDITIONAL DAMAGE APPEARING NOT TO BE COMPLAINT RELATED: THE RESHEATHING TOOL WAS RETURNED SEVERED INTO TWO PIECES. THE RESHEATHING TOOL¿S FRACTURE IS DUCTILE IN NATURE REQUIRING EXTERNAL FORCE. NO MATERIAL DEFECTS WERE FOUND. THE PROXIMAL SECTION OF THE SHEATH CONTAINING THE PULL SECTION WAS SEVERED AND NOT RETURNED. LOCATED ON THE TOP PROXIMAL END OF THE RESHEATHING TOOL IN THE OPEN CUTOUT SECTION, THE V NOTCH HAS BEEN SEVERELY FRACTURED WITH THE DAMAGED EDGES RAISED ABOVE THE SURFACE PLANE. NO MANUFACTURING DEFECTS WERE FOUND. THIS DAMAGE MOST LIKELY OCCURRED WHEN THE MICROCOIL SYSTEM WAS FIRST UNLOCKED FOR USE AND THE SHEATH WAS RETRACTED STRAIGHT BACK INSTEAD OF UP AT A FORTY-FIVE DEGREE ANGLE AND THEN BACK. WHEN THE SHEATH WAS PULLED STRAIGHT BACK, THE LOCKING MECHANISM CAUGHT THE INSIDE OF THE V NOTCH OF THE RESHEATHING TOOL AND BECAME EMBEDDED. IN ADDITION, THE LOCKING MECHANISM MAY NOT HAVE BEEN FULLY DISENGAGED OFF THE CORE WIRE. THE SHEATH ALSO CAUGHT THE V NOTCHES EXTENDED EDGES. THIS PRODUCED A BINDING ACTION BETWEEN THE DEVICE POSITIONING UNIT (DPU), THE SHEATH, AND THE COIL. THIS BINDING ACTION PRODUCED SIGNIFICANT RESISTANCE WHICH MAY HAVE FRACTURED THE RESHEATHING TOOL, SEVERED THE SHEATH¿S PULL TAB, AND MAY HAVE CAUSED EXTREME RESISTANCE WHEN ATTEMPTING TO ADVANCE THE COIL. FOR OPTIMUM PRODUCT PERFORMANCE AND TO PREVENT POTENTIAL COMPLICATIONS, THE INSTRUCTIONS FOR USE (IFU) RECOMMENDS, ¿HOLD THE INTRODUCER SHEATH (LOOSELY-LOOPED) IN THE LEFT HAND. KEEPING THE INTRODUCER TIP NEAR THE RE-SHEATHING TOOL, GRASP THE DISTAL END OF THE RE-SHEATHING TOOL BETWEEN YOUR LEFT THUMB AND FOREFINGER. GRASP THE CLEAR TAB NEAR THE END OF THE INTRODUCER SHEATH BODY WITH THE THUMB AND FOREFINGER OF YOUR OTHER HAND. GENTLY PULL THE CLEAR TAB OF THE INTRODUCER SHEATH OUT AND AWAY FROM THE RE SHEATHING TOOL AT A 45-DEGREE ANGLE TO UNLOCK THE MICROCOIL. CONTINUE TO PULL THE TAB UNTIL AN ADDITIONAL 0.5 TO 1.0 INCHES (1.3 TO 2.5 CM) OF THE TRANSLUCENT MATERIAL IS EXPOSED. GENTLY FOLD THE TRANSLUCENT TAB TOWARDS THE DISTAL END, AND FIRMLY GRASP THE DISTAL END OF THE RE SHEATHING TOOL AND THE TRANSLUCENT TAB BETWEEN YOUR THUMB AND FOREFINGER, AS SHOWN IN FIGURE 3¿¿ CAUTION: IF UNUSUAL FRICTION IS NOTICED DURING ADVANCEMENT OR RETRACTION OF THE MICROCOIL SYSTEM, VERIFY THE LOCKING MECHANISM, OR CLEAR TAB IS UNLOCKED AND PULLED OUT FROM THE RESHEATHING TOOL APPROXIMATELY 1IN. (2-3CM).¿ ADDITIONAL IFU RECOMMENDATIONS: IT WAS STATED THAT AN SL-10 MICROCATHETER 10 SERIES WAS SELECTED FOR USE WITH AN INCOMPATIBLE 18 SERIES MICROCOIL SYSTEM. IT APPEARS THAT NO DAMAGE WAS RELATED TO THIS USE AND THIS IS ONLY AN IFU RECOMMENDATION AS ALL DEVICE USE IS DICTATED BY THE ATTENDING PHYSICIAN. FOR OPTIMUM PRODUCT PERFORMANCE AND TO PREVENT POTENTIAL COMPLICATIONS, THE INSTRUCTIONS FOR USE (IFU) RECOMMENDS, ¿PROPER SELECTION OF THE APPROPRIATELY SIZED MICROCATHETER IS REQUIRED TO AVOID DAMAGE TO THE CODMAN MICROCOIL SYSTEM AND TO MINIMIZE POTENTIAL COMPLICATIONS. MICROCATHETER SELECTION IS ALSO DETERMINED BY THE PHYSICIAN AND IS PREDICATED BY THE LOCATION OF THE ANEURYSM, PATIENT SAFETY, AND PHYSICIAN PREFERENCE. THE CODMAN MICROCOIL 18 SYSTEM IS COMPATIBLE WITH MICROCATHETERS WITH INNER LUMEN DIAMETERS RANGING FROM 0.017 TO 0.021 IN (0.356 TO 0.533 MM). THE SL-10 MICROCATHETER HAS AN INNER LUMEN OF 0.0165¿. BASED ON THE INFORMATION AND THE ANALYSIS, THE EVENT COULD NOT BE CONFIRMED, HOWEVER PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. ADDITIONALLY, A REVIEW OF 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

    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 PRODUCT WAS RECEIVED FOR ANALYSIS, BUT IT HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: SL-10 MICROCATHETER (DETAILS UNKNOWN).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HOSPITAL THAT THE PHYSICIAN SUCCESSFULLY PLACED THE COIL (CSP18050030/C27689) THROUGH AN SL-10 MICROCATHETER (DETAILS UNKNOWN) INTO AN ACOM ANEURYSM. WHEN HE TRIED TO DETACH THE COIL IT WOULD NOT DETACH. SEVERAL ATTEMPTS WERE MADE TO DETACH, BUT WERE NOT SUCCESSFUL. THE COIL WILL BE RETURNED FOR ANALYSIS. PATIENT DEATH OR SERIOUS INJURY DID NOT OCCUR AS A RESULT OF THE EVENT. ADDITIONAL MEDICAL INTERVENTION OR MEDICATION WAS NOT REQUIRED TO PREVENT IMPAIRMENT OR INJURY. THERE WERE NO DAMAGES NOTED ON THE COIL AFTER USE. THE SAME MICROCATHETER, DETACHMENT CONTROL BOX (DETAILS UNKNOWN), AND CONNECTING CABLE (DETAILS UNKNOWN) WERE USED TO COMPLETE THE PROCEDURE. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE LOW BATTERY LIGHT WAS SEEN DURING THE CASE. THE FAULT LIGHT WAS NOT SEEN DURING THE CASE. THE GREEN SYSTEM READY LIGHT ILLUMINATED. DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT ILLUMINATED. THE AUDIBLE SIGNAL BEEPED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THERE WAS NO RESISTANCE DURING DEPLOYMENT OF THE COIL SYSTEM THROUGH THE MICROCATHETER. TORQUING OF THE DPU WAS NOT REQUIRED DURING POSITIONING OF THE COIL IN THE ANEURYSM. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134820 MICRUSPHERE 18 - CERECYTE MICROCOIL CNV DCS COILS HCG CODMAN AND SHURTLEFF, INC C27689

    Patients

    Seq Age Sex Outcome Treatment
    1