BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPLUSH - CERECYTE MICROCOIL

    MDR report key: 3060558 · Received April 16, 2013

    Report

    Report Number
    1226348-2013-20069
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    November 23, 2012
    Report Date
    November 26, 2012
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K083646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COIL WAS RETURNED WITH THE SOCKET RING PUSHED DOWN INSIDE THE OUTER SHEATH. THE PROXIMAL SECTION OF THE COIL HAS BEEN SECONDARY COILING TO ANGLE OFF FROM THE REMAINING COILING. DRIED GRANULIZED CONTRAST WAS FOUND ADHERING TO THE INTERNAL AND EXTERNAL AREAS OF THE MICROCOIL AND OUTER SHEATH. THE SHEATH'S LOCKING MECHANISM WAS FOUND DAMAGED WITH THE MATERIAL COMPRESSED AND STRETCHED AWAY FROM THE SURFACE. IT IS IMPORTANT TO NOTE THAT THE COMPLAINT WAS THAT IT WAS 'IMPOSSIBLE TO ADVANCE THE COIL OUT OF THE DELIVERY SYSTEM,' HOWEVER UPON RECEIPT OF THE MICROCOIL SYSTEM, THE COIL WAS FREELY ADVANCED OUT OF THE INTRODUCER SHEATH AS RECEIVED AND WITHOUT ANY CLEANING OR MANIPULATION. LABORATORY TESTING COULD NOT DUPLICATE THE FIELD COMPLAINT. HOWEVER, THE EVIDENCE AS RECEIVED SHOWS THAT THERE ARE TWO POSSIBLE CONTRIBUTING FACTORS TO THE COILS INABILITY TO BE ADVANCED. THE PRIMARY CONTRIBUTING FACTOR MAY HAVE OCCURRED WHEN THE LOCKING MECHANISM AND/OR ANOTHER SECTION OF THE SHEATH CAUGHT THE V NOTCH SECTION OF THE RESHEATHING TOOL. THIS MAY HAVE OCCURRED WHEN THE DEVICE WAS FIRST UNLOCKED FOR USE AND THE SHEATH'S PULL TAB WAS RETRACTED STRAIGHT BACK INSTEAD OF UP AT A FORTY-FIVE DEGREE ANGLE AND THEN BACK. THIS MAY HAVE CAUSED THE SHEATH TO CATCH THE V NOTCH OF THE RESHEATHING TOOL. THIS WOULD HAVE CAUSED A BINDING ACTION BETWEEN THE DEVICE POSITIONING UNIT (DPU), THE SHEATH, AND FINALLY THE COIL. THIS WOULD HAVE PRODUCED SIGNIFICANT RESISTANCE WHEN ATTEMPTING TO ADVANCE THE COIL. THIS WOULD HAVE ALSO HAVE PRODUCED COIL DAMAGE. IF THIS DID OCCUR THEN 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.' THE SECONDARY CONTRIBUTING FACTOR TO THE COILS INABILITY TO BE ADVANCED MAY HAVE BEEN DUE TO DISTAL INTERFERENCE. THIS INTERFERENCE MOST LIKELY OCCURRED IN THE HUB TO MICROCATHETER JUNCTION OR INSIDE THE MICROCATHETER'S TUBE ITSELF. THIS WOULD EXPLAIN THE EXTENSIVE AMOUNT OF DRIED CONTRAST GRANULES FOUND ON AND INSIDE THE MICROCOIL SYSTEM AND THAT THE COIL WAS WITHDRAWN WITHOUT DETACHING AS STATED IN THE EVENT DESCRIPTION. THE PREVIOUS STATEMENT MEANS THAT A PORTION OF THE COIL DID EXTEND PAST THE DISTAL TIP OF THE GREEN INTRODUCER AND INTO THE MICROCATHETER. THE SOURCE OF THIS INTERFERENCE WHETHER OF A FIXED OR DETACHED NATURE CANNOT BE DETERMINED. IN ADDITION, WITHOUT THE IDENTIFICATION OR RETURN OF THE UNKNOWN MICROCATHETER AND THE ROTATING HEMOSTATIC VALVE (RHV) USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS CONTRIBUTED TO THE COMPLAINT EVENT. 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. EVALUATION SUMMARY ATTACHED.

    Additional Manufacturer Narrative · 1

    CONCLUSION: IT WAS REPORTED THAT THE 1.5 MM X 3 CM DELTAPLUSH CERECYTE MICROCOIL ((B)(4), LOT G14715) COULD NOT BE ADVANCED OUT OF THE DELIVERY DEVICE. FURTHER INFORMATION REPORTED THAT IT OCCURRED PRIOR TO USE IN THE PATIENT WITH NO PATIENT INJURY. THE PROCEDURE WAS CONTINUED WITH THE SAME LIKE PRODUCT. THE COIL DID NOT PREMATURELY DETACH. ANALYSIS OF THE RETURNED DEVICE FOUND THE COIL WAS STRETCHED. WITH FOLLOW-UP IT WAS REPORTED THAT COIL STRETCHING OCCURRED DURING THE PROCEDURE, PRIOR TO USE IN THE PATIENT. THE COIL WAS RETURNED WITH THE SOCKET RING PUSHED DOWN INSIDE THE OUTER SHEATH. THE PROXIMAL SECTION OF THE COIL HAS BEEN SECONDARY COILING TO ANGLE OFF FROM THE REMAINING COILING. DRIED GRANULIZED CONTRAST WAS FOUND ADHERING TO THE INTERNAL AND EXTERNAL AREAS OF THE MICROCOIL AND OUTER SHEATH. THE SHEATH'S LOCKING MECHANISM WAS FOUND DAMAGED WITH THE MATERIAL COMPRESSED AND STRETCHED AWAY FROM THE SURFACE. IT IS IMPORTANT TO NOTE THAT THE COMPLAINT WAS THAT IT WAS 'IMPOSSIBLE TO ADVANCE THE COIL OUT OF THE DELIVERY SYSTEM,' HOWEVER UPON RECEIPT OF THE MICROCOIL SYSTEM, THE COIL WAS FREELY ADVANCED OUT OF THE INTRODUCER SHEATH AS RECEIVED AND WITHOUT ANY CLEANING OR MANIPULATION. LABORATORY TESTING COULD NOT DUPLICATE THE FIELD COMPLAINT. HOWEVER, THE EVIDENCE AS RECEIVED SHOWS THAT THERE ARE TWO POSSIBLE CONTRIBUTING FACTORS TO THE COILS INABILITY TO BE ADVANCED. THE PRIMARY CONTRIBUTING FACTOR MAY HAVE OCCURRED WHEN THE LOCKING MECHANISM AND/OR ANOTHER SECTION OF THE SHEATH CAUGHT THE V NOTCH SECTION OF THE RESHEATHING TOOL. THIS MAY HAVE OCCURRED WHEN THE DEVICE WAS FIRST UNLOCKED FOR USE AND THE SHEATH'S PULL TAB WAS RETRACTED STRAIGHT BACK INSTEAD OF UP AT A FORTY-FIVE DEGREE ANGLE AND THEN BACK. THIS MAY HAVE CAUSED THE SHEATH TO CATCH THE V NOTCH OF THE RESHEATHING TOOL. THIS WOULD HAVE CAUSED A BINDING ACTION BETWEEN THE DEVICE POSITIONING UNIT (DPU), THE SHEATH, AND FINALLY THE COIL. THIS WOULD HAVE PRODUCED SIGNIFICANT RESISTANCE WHEN ATTEMPTING TO ADVANCE THE COIL. THIS WOULD HAVE ALSO HAVE PRODUCED COIL DAMAGE. IF THIS DID OCCUR THEN FOR OPTIMUM PRODUCT PERFORMANCE AND TO PREVENT POTENTIAL COMPLICATIONS, THE INSTRUCTIONS FOR USE (IFU) OUTLINES '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' THIS IS ALSO SHOWN DIAGRAMMATICALLY. THE SECONDARY CONTRIBUTING FACTOR TO THE COILS INABILITY TO BE ADVANCED MAY HAVE BEEN DUE TO DISTAL INTERFERENCE IF IT OCCURRED DURING ATTEMPTED INTRODUCTION INTO THE MICROCATHETER. IN THIS SCENARIO THE INTERFERENCE WOULD MOST LIKELY OCCUR IN THE HUB TO MICROCATHETER JUNCTION OR INSIDE THE MICROCATHETER'S TUBE ITSELF. THIS WOULD EXPLAIN THE EXTENSIVE AMOUNT OF DRIED CONTRAST GRANULES FOUND ON AND INSIDE THE MICROCOIL SYSTEM AND THAT THE COIL WAS WITHDRAWN WITHOUT DETACHING AS STATED IN THE EVENT DESCRIPTION. IN THIS SCENARIO A PORTION OF THE COIL WOULD EXTEND PAST THE DISTAL TIP OF THE GREEN INTRODUCER AND INTO THE MICROCATHETER. THE SOURCE OF INTERFERENCE IN THIS SCENARIO, WHETHER OF A FIXED OR DETACHED NATURE, CANNOT BE DETERMINED. IN ADDITION, WITHOUT THE IDENTIFICATION OR RETURN OF THE UNKNOWN MICROCATHETER AND THE ROTATING HEMOSTATIC VALVE (RHV) USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS CONTRIBUTED TO THE COMPLAINT EVENT. 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. BASED ON THE ANALYSIS OF THE RETURNED DEVICE AND THE PROVIDED INFORMATION A DEFINITIVE ROOT CAUSE OF THE REPORTED EVENT AND STRETCHED COIL CANNOT BE DETERMINE. HOWEVER, THERE IS NO INDICATION OF ANY RELATIONSHIP TO THE MANUFACTURING PROCESS WITH PROCEDURAL FACTORS APPEAR TO HAVE IMPACTED THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    NOTE: FINAL ANALYSIS FOUND STRETCHED COIL. THEREFORE, THE REPORTABILITY STATUS CHANGED FROM NON REPORTABLE TO REPORTABLE. AS REPORTED, THE CUSTOMER REPORTED THAT IT WAS IMPOSSIBLE TO ADVANCE THE COIL ((B)(4), LOT G14715) OUT OF THE DELIVERY DEVICE. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE INDICATED THAT THE EVENT OCCURRED PRIOR TO USE ON THE PATIENT. THE COIL DID NOT PREMATURELY DETACH DURING THE PROCESS OF WITHDRAWAL. THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162346 DELTAPLUSH - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA G14715

    Patients

    Seq Age Sex Outcome Treatment
    1