BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPAQ - CERECYTE MICROCOIL

    MDR report key: 3033786 · Received April 3, 2013

    Report

    Report Number
    1226348-2013-20064
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K080437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING POSITIONING AT THE BASILAR ARTERY ANEURYSM TARGET SITE, THE DELTAPAQ CERECYTE MICROCOIL 1.5 MM X 2 CM (CDF10015230/M10252) WAS FOUND TO BE STRETCHED. THE COIL WAS WITHDRAWN AND CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. THE COIL DID NOT PREMATURELY DETACH WHEN IT WAS REMOVED FROM THE PATIENT. THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. COIL ENTANGLEMENT WITH PREVIOUSLY PLACED COILS WAS NOT SUSPECTED TO CONTRIBUTE TO THE EVENT. THERE WAS NO RESISTANCE WHEN THE COIL WAS INSERTED THROUGH THE MICROCATHETER AND WHEN THE COIL WAS POSITIONED AT THE TARGET SITE. EXCEPT FOR THE FIRST SECONDARY WINDING OFF THE BALL TIP, THE REMAINDER OF THE COIL HAS BEEN STRETCHED. THE 2.0 CENTIMETER COIL WAS STRETCHED 6.4 CENTIMETERS. THE PROXIMAL END OF THE COIL HAS MULTIPLE SECTIONS OF BUCKLING DAMAGE. THE MOST LIKELY CONTRIBUTING FACTOR TO THE ROOT CAUSE OF THE COIL STRETCHED OCCURRED DURING REPOSITIONING WHEN THE COIL BECAME TEMPORARILY ANCHORED. THE EXACT CAUSE OF THE LIKELY ANCHORING OF THE COIL DURING POSITIONING CANNOT BE CONCLUDED; HOWEVER, POTENTIAL CAUSES INCLUDE IT HAVING BECOME ANCHORED ON THE COILS ALREADY DWELLING INSIDE THE ANEURYSM, ON ITSELF, OR ON THE DISTAL TIP OF THE MICROCATHETER. RETRACTION WHEN THE COIL IS ANCHORED WILL RESULT IN STRETCHING. FOR OPTIMUM PRODUCT PERFORMANCE AND TO PREVENT POTENTIAL COMPLICATIONS, THE INSTRUCTIONS FOR USE (IFU) OUTLINES 'CAUTION: IF REPOSITIONING OF THE MICROCOIL IS NECESSARY, CAREFULLY OBSERVE THE MOTION OF THE MICROCOIL IN RESPECT TO THE DPU WIRE WHILE RETRACTING THE MICROCOIL UNDER FLUOROSCOPY. IF THE MICROCOIL MOVEMENT IS NOT ONE-TO-ONE WITH THE DPU WIRE, OR IF REPOSITIONING IS DIFFICULT, THE MICROCOIL MAY HAVE BECOME STRETCHED AND COULD POSSIBLY BREAK. GENTLY REMOVE AND DISCARD THE MICROCOIL SYSTEM. CAUTION: IF THE MICROCOIL IS POSITIONED AT A RELATIVE SHARP ANGLE TO THE MICROCATHETER, A MICROCOIL MAY STRETCH OR BREAK AS IT IS BEING WITHDRAWN. BY REPOSITIONING THE DISTAL TIP OF THE CATHETER AT OR SLIGHTLY INSIDE THE OSTIUM OF THE ANEURYSM, THE MICROCOIL MAY BE MORE EASILY FUNNELED BACK INTO THE MICROCATHETER.' IN ADDITION, WITHOUT THE IDENTIFICATION OR THE RETURN OF THE UNKNOWN MICROCATHETER USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THIS COMPONENT 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. WITH REVIEW OF THE AVAILABLE REPORTED INFORMATION AND THE ANALYSIS OF THE RETURNED DEVICE, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE STRETCHING OF THE COIL. PROCEDURAL/CLINICAL FACTORS LEADING TO ANCHORING OF THE DEVICE DURING REPOSITIONING APPEAR TO HAVE CONTRIBUTED TO THE STRETCHING OF THE COIL. WITH REVIEW OF THE AVAILABLE INFORMATION, THE ANALYSIS OF THE RETURNED DEVICE, AND DEVICE HISTORY RECORDS THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES. A DEFINITIVE ROOT CAUSE CONCLUSION CANNOT BE MADE; 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 WILL BE RETURNED FOR ANALYSIS, HOWEVER IT HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: - NEW COIL (DETAILS UNKNOWN). - MICROCATHETER (DETAILS UNKNOWN).

    Description of Event or Problem · 1

    DURING POSITIONING AT THE TARGET SITE, THE DELTAPAQ CERECYTE MICROCOIL 1.5 MM X 2 CM (CDF10015230/M10252) WAS FOUND TO BE STRETCHED. THE COIL WAS WITHDRAWN AND CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. COIL ENTANGLEMENT WITH PREVIOUSLY PLACED COILS WAS NOT SUSPECTED TO CONTRIBUTE TO THE EVENT. THE COIL DID NOT PREMATURELY DETACH WHEN IT WAS REMOVED FROM THE PATIENT. THERE WAS NO RESISTANCE WHEN THE COIL WAS INSERTED THROUGH THE MICROCATHETER AND WHEN THE COIL WAS POSITIONED AT THE TARGET SITE. THIS IS NOT A POTENTIAL ADVERSE EVENT. THE PATIENT HAD BASILAR ARTERY ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136714 DELTAPAQ - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA M10252

    Patients

    Seq Age Sex Outcome Treatment
    1