BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRUSPHERE 10 - PLATINUM MICROCOIL

    MDR report key: 3961499 · Received July 28, 2014

    Report

    Report Number
    1226348-2014-00163
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K002056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE DEVICE HAS BEEN RETURNED FOR ANALYSIS; HOWEVER, THE DEVICE HAS NOT YET BEEN RETURNED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    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. PRODUCT ANALYSIS PENDING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 7/30/2014. THE STRETCHED COIL WAS NOTED AFTER REMOVING THE DEVICE FROM THE HOOP, AND THERE HAD BEEN NO DIFFICULTY IN REMOVING THE DEVICE FROM THE PACKAGING OR EXPOSING THE COIL FOR PRE-USE INSPECTION. THE PACKAGE WAS NOT DAMAGED. THERE WERE NO KNOWN FACTORS THAT MAY HAVE CONTRIBUTED TO THE STRETCHING. THERE WAS NO SIGNIFICANT DELAY IN THE PROCEDURE. COMPLAINT CONCLUSION: DURING COIL EMBOLIZATION OF A POSTERIOR COMMUNICATING ARTERY ANEURYSM, AFTER REMOVING THE DEVICE FROM THE HOOP, THE SURGEON NOTED THAT THE MICRUSPHERE COIL (SPH10040020/C13597)WAS ALREADY PARTLY STRETCHED. THERE HAD BEEN NO DIFFICULTY IN REMOVING THE COIL FROM THE PACKAGING OR EXPOSING THE COIL FOR PRE-USE INSPECTION AND THE PACKAGING DID NOT APPEAR DAMAGED. THERE WERE NO KNOWN FACTORS THAT MAY HAVE CONTRIBUTED TO THE STRETCHING, AND THERE WAS NO SIGNIFICANT DELAY IN THE PROCEDURE. HE CHANGED TO ANOTHER COIL TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION COULD BE OBTAINED. THE DEVICE WAS RETURNED FOR ANALYSIS. THE COIL WAS FOUND TO BE STRETCHED. LOCATED AFTER THE FIRST SECONDARY WINDING OFF THE BALL TIP; IS A SECTION OF A STRETCHED COIL. THE COIL¿S SOCKET RING HAS BEEN PUSHED DOWN INSIDE THE OUTER SHEATH. THE DISTAL TIP OF THE DEVICE POSITIONING UNIT (DPU) AND THE PROXIMAL END OF THE COIL ARE NO LONGER CONCENTRIC TO EACH OTHER. LOCATED 1.5 CENTIMETERS OFF THE DISTAL TIP OF THE GREEN INTRODUCER IS A SECTION OF SEVERE COMPRESSION. LOCATED ON THE TOP PROXIMAL END OF THE RESHEATHING TOOL IN THE OPEN CUTOUT SECTION, THE V NOTCH HAS BEEN FRACTURED. THE LOCKING MECHANISM HAS COMPRESSION AND STRETCHING DAMAGE. THERE ARE TWO POSSIBLE CONTRIBUTING FACTORS TO THE COIL STRETCHING. THESE CONTRIBUTING FACTORS MAY HAVE WORKED IN TANDEM OR SEPARATELY WITH EACH CAPABLE OF PRODUCING SIMILAR DAMAGE TO THE COIL. THE PRIMARY CONTRIBUTING FACTOR TO THE COIL STRETCHING AT THE DISTAL SECTION MAY HAVE OCCURRED WHEN THE DISTAL TIP OF THE COIL BECAME ANCHORED IN THE SEVERELY COMPRESSED SECTION OF THE GREEN INTRODUCER. WHEN THE TEMPORARILY ANCHORED COIL WAS RETRACTED IT MOST LIKELY STRETCHED AT THE DISTAL SECTION. THE CIRCUMSTANCES OF WHEN AND HOW THE DISTAL SECTION OF THE GREEN INTRODUCER WAS COMPRESSED CANNOT BE DETERMINED. THE SECONDARY CONTRIBUTING FACTOR TO THE COIL DAMAGE MAY HAVE 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 PUSHED THE COILS SOCKET RING DOWN INSIDE THE OUTER SHEATH AND MAY HAVE CAUSED A PORTION OF THE COIL DAMAGE FOUND. THE CIRCUMSTANCES OF WHEN AND WHERE THIS DAMAGE OCCURRED CANNOT BE DETERMINED AS ALL COILS ARE INSPECTED ONE HUNDRED PERCENT PRIOR TO FINAL PACKAGING. 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¿¿ 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).¿ 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 STRETCHED COIL WAS CONFIRMED THROUGH PRODUCT ANALYSIS; HOWEVER, THE ROOT CAUSE OF THE STRETCHING COULD NOT BE CONFIRMED. BASED ON THE CONDITION OF THE RETURNED DEVICE, IT APPEARS THAT THE DEVICE HAD BEEN UNSHEATHED, AND HANDLING FACTORS THAT ARE ADDRESSED IN THE IFU MAY HAVE CONTRIBUTED TO THE DAMAGES FOUND DURING ANALYSIS. THERE WAS NO EVIDENCE THAT THE COMPLAINT WAS RELATED TO A MANUFACTURING ISSUE; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING COIL EMBOLIZATION OF A POSTERIOR COMMUNICATING ARTERY ANEURYSM, THE SURGEON OPENED THE PACKAGE OF THE MICRUSPHERE COIL (SPH10040020/C13597), BUT NOTED THAT THE COIL WAS ALREADY PARTLY STRETCHED. HE CHANGED TO ANOTHER COIL. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437539 MICRUSPHERE 10 - PLATINUM MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA C13597

    Patients

    Seq Age Sex Outcome Treatment
    1