BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELIPAQ 18 - CERECYTE MICROCOIL

    MDR report key: 3212866 · Received July 9, 2013

    Report

    Report Number
    1226348-2013-20125
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 20, 2013
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K022420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING CAROTID OPHTHALMIC ANEURYSM PROCEDURE, THE FIRST HELIPAQ 18 CERECYTE MICROCOIL (CHE18143030/M10288) WAS USED BECAUSE IT COMPLIED WITH THE DIMENSIONS OF ANEURYSM, BUT WHEN THE COIL WAS PROPEL BY DEVICE POSITIONING UNIT, THE COIL SEPARATED FROM THE DELIVERY SYSTEM (SENSATION OF A COARSE DISPLACEMENT FROM THE BEING) IN THE Y CONNECTOR DURING ADVANCEMENT. DURING INSERTION, THE COIL INTRODUCER WAS NOT COMPLETELY SEATED IN THE MICROCATHETER HUB, AND THE COIL AND PUSHER SEPARATED. DURING INSERTION, THE Y CONNECTOR WAS OPENED SUFFICIENTLY TO ALLOW THE PASSAGE OF THE COIL DELIVERY SYSTEM/INTRODUCER. ADDITIONALLY, DURING INSERTION, THE TOUHY OR Y CONNECTOR WAS CLOSED TO SECURE THE COIL DELIVERY SYSTEMS/INTRODUCERS AND PREVENT MOVEMENT, AND THERE WAS NO POSSIBILITY THAT THE Y CONNECTOR WAS OVER TIGHTENED. THERE WERE NO DAMAGES NOTICED ON ANY SECTION OF THE DELIVERY SYSTEM THAT MAY HAVE CONTRIBUTED TO THE EVENT, AND THE DEVICE WAS IN GOOD CONDITION AFTER THE SURGERY. NO ADDITIONAL TORQUE OR MANIPULATION WAS REQUIRED TO ADVANCE THE COIL THROUGH THE INTRODUCER, AND A CONSTANT AND DEDICATED SALINE SOURCE WAS USED AT ALL TIMES THROUGH THE MICROCATHETER. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE REPORTED (DELIVERY SYSTEM/COIL (UNRAVELED, STRETCHED, KINK, BEND, FRACTURE, SEPARATED, ETC). PRIOR TO THE EVENT AN ENVOY 6FRENCH CATHETER WAS USED AND POSITIONED IN THE RIGHT INTERNAL CAROTID ARTERY, AND AFTER A SL-10 MICROCATHETER (BOSTON SCIENTIFIC) WAS USED WITH AN AGILITY 14 SOFT GUIDEWIRE TO INTRODUCE INTO ANEURYSM POUCH. THE INTENDED TARGET SITE WAS THE RIGHT HORIZONTAL SEGMENT OF THE ANTERIOR CEREBRAL ARTERY. IT IS CONFIRMED COIL WAS RETURNED SEPARATED FROM THE DEVICE POSITIONING UNIT (DPU) VIA THE DETACHMENT FIBER. THE DETACHMENT OF THE COIL WAS MECHANICAL IN NATURE. THE DETACHED COIL WAS FOUND INSIDE THE INTRODUCER SHEATH. THE PROXIMAL END OF THE COIL WAS PROTRUDING OUTSIDE THE SHEATH. THE COIL¿S SOCKET RING WAS SEVERED AND UNRAVELED OUT OF THE SOLDERED SECTION ON ONE SIDE. NO MATERIAL DEFECTS WERE PRESENT. THE DPU AND THE INTRODUCER SHEATH WERE RETURNED SEPARATED FROM EACH OTHER. THE PROXIMAL SECTION OF THE COIL WAS ALSO STRETCHED AT THE PROTRUSION SITE. THERE ARE MULTIPLE BUCKLED SECTIONS AT THE MIDDLE SECTION OF THE COIL. THE FIRST SECONDARY WINDING OFF THE BALL TIP HAS BEEN BUCKLED. LOCATED ON THE TOP PROXIMAL END OF THE RESHEATHING TOOL IN THE OPEN CUTOUT SECTION, THE V NOTCH HAS BEEN SEVERELY DAMAGED. LOCATED AT AND DISTAL TO THE LOCKING MECHANISM IS COMPRESSION AND STRETCHING DAMAGE TO THE SHEATH. THE MOST LIKELY PRIMARY CONTRIBUTING FACTOR TO THE COILS INABILITY TO BE ADVANCED INTO THE MICROCATHETER, ITS EVENTUAL PROTRUSION OUTSIDE THE SHEATH, THE RESULTING COIL DAMAGE, AND ITS UNINTENDED MECHANICAL DETACHMENT 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 DID CATCH 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. THIS PRODUCED A BINDING ACTION BETWEEN THE DEVICE POSITIONING UNIT (DPU), THE SHEATH, AND THE COIL. THIS BINDING ACTION PRODUCED SIGNIFICANT RESISTANCE CAUSING THE COILS INABILITY TO BE ADVANCED INTO THE MICROCATHETER, THE PROTRUSION OF THE COIL OUTSIDE THE SHEATH, THE SEVERE COIL DAMAGE, AND ITS UNINTENDED MECHANICAL DETACHMENT FROM THE DETACHMENT FIBER. 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).¿ IN ADDITION, WITHOUT THE RETURN OF THE SL-10 MICROCATHETER AND THE ROTATING HEMOSTATIC VALVE (RHV) USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS HAD ANY ADDITIONAL CONTRIBUTIONS TO THE COMPLAINT EVENT. IT WAS NOT STATED IN THE EVENT DESCRIPTION HOW FAR THE COIL TRAVELED BEFORE IT COULD NO LONGER BE ADVANCED. IF THE COIL ENTERED THE MICROCATHETER¿S TUBE PAST THE HUB TO MICROCATHETER JUNCTION THEN IT IS POSSIBLE THAT THE SELECTION OF AN INCOMPATIBLE 10 SERIES MICROCATHETER WAS USED WITH AN 18 SERIES MICROCOIL SYSTEM WHICH MAY HAVE CONTRIBUTED TO THE FIELD COMPLAINT. IF THIS DID OCCUR THEN 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 MICRUS 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 MICRUS 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 INNER LUMEN OF A SL-10 MICROCATHETER IS 0.0165¿. 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 (COIL SEPARATING FROM THE DELIVERY SYSTEM AND SEPARATED INTRODUCER) WAS CONFIRMED WITH ANALYSIS, AND THE CAUSE MAY BE RELATED TO PROCEDURAL AND HANDLING FACTORS. ADDITIONALLY, THE ANALYSIS ADDS LABELING GUIDELINES TO PROVIDE GUIDANCE IN USE OF THE DEVICE. ADDITIONALLY, DHR INDICATED THAT 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

    CONCOMITANT PRODUCTS: ENVVOY CATHETER, SL 10 MICROCATHETER, & Y CONNECTOR. 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 WILL BE RETURN FOR ANALYSIS, BUT IT HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING CAROTID OPHTHALMIC ANEURYSM PROCEDURE, THE FIRST HELIPAQ 18 CERECYTE MICROCOIL (CHE18143030/M10288) WAS USED BECAUSE IT COMPLIED WITH THE DIMENSIONS OF ANEURYSM, BUT WHEN WE COIL WAS PROPEL BY DEVICE POSITIONING UNIT, THE COIL SEPARATED FROM THE DELIVERY SYSTEM (SENSATION OF A COARSE DISPLACEMENT FROM THE BEING) IN THE Y CONNECTOR DURING ADVANCEMENT. DURING INSERTION, THE COIL INTRODUCER WAS NOT COMPLETELY SEATED IN THE MICROCATHETER HUB, AND DURING INSERTION, THE Y CONNECTOR WAS OPENED SUFFICIENTLY TO ALLOW THE PASSAGE OF THE COIL DELIVERY SYSTEM/INTRODUCER. ADDITIONALLY, DURING INSERTION, THE TOUHY OR Y CONNECTOR WAS CLOSED TO SECURE THE COIL DELIVERY SYSTEMS/INTRODUCERS AND PREVENT MOVEMENT, AND THERE WAS NO POSSIBILITY THAT THE Y CONNECTOR WAS OVER TIGHTENED. THERE WERE NO DAMAGES NOTICED ON ANY SECTION OF THE DELIVERY SYSTEM THAT MAY HAVE CONTRIBUTED TO THE EVENT, AND THE DEVICE WAS IN GOOD CONDITION AFTER THE SURGERY. NO ADDITIONAL TORQUE OR MANIPULATION WAS REQUIRED TO ADVANCE THE COIL THROUGH THE INTRODUCER, AND A CONSTANT AND DEDICATED SALINE SOURCE WAS USED AT ALL TIMES THROUGH THE MICROCATHETER. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE REPORTED (DELIVERY SYSTEM/COIL (UNRAVELED, STRETCHED, KINK, BEND, FRACTURE, SEPARATED, ETC). PRIOR TO THE EVENT AN ENVOY 6FRENCH CATHETER WAS USED AND POSITIONED IN THE RIGHT INTERNAL CAROTID ARTERY, AND AFTER A SL-10 MICROCATHETER (BOSTON SCIENTIFIC) WAS USED WITH AN AGILITY 14 SOFT GUIDEWIRE TO INTRODUCE INTO ANEURYSM POUCH. THE INTENDED TARGET SITE WAS THE RIGHT HORIZONTAL SEGMENT OF THE ANTERIOR CEREBRAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313471 HELIPAQ 18 - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA M10288

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR