BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESIDIO 18 - CERECYTE MICROCOIL

    MDR report key: 3950002 · Received July 22, 2014

    Report

    Report Number
    1226348-2014-00157
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 27, 2014
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K002056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    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. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR ANALYSIS ON 7/23/2014; HOWEVER, THE ACTUAL COIL WAS NOT RETURNED. COMPLAINT CONCLUSION: DURING COIL EMBOLIZATION OF A SPLENIC ARTERY ANEURYSM, AS THE PHYSICIAN WAS POSITIONING A PRESIDIO COIL (PC182050-30/C24508) THROUGH A NON-CODMAN MICROCATHETER, IT FELT ABNORMAL, AND AFTER SAFELY REMOVING THE COIL FROM THE PATIENT, THE COIL WAS FOUND TO BE STRETCHED/UNRAVELED. THIS WAS THE FIRST COIL USED. THE PHYSICIAN USED A NEW PRESIDIO COIL (LOT UNKNOWN) AND A CASHMERE COIL (LOT UNKNOWN) TO SUCCESSFULLY COMPLETE THE PROCEDURE USING THE SAME MICROCATHETER WITH NO PATIENT INJURY/COMPLICATIONS REPORTED. THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND A CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. PRIOR TO USE, NO DEFECT (KINK, BENDS, ETC.) WAS NOTED ON THE PRODUCTS BY VISUAL INSPECTION, AND THERE HAD BEEN NO REPORTED DIFFICULTY WHILE UNZIPPING THE DEVICE, OR RESISTANCE FRICTION BETWEEN THE DEVICE AND THE MICROCATHETER. ALSO NO DAMAGES WERE REPORTED ON THE DEVICES AFTER THE EVENT, BUT THE COIL WAS DETACHED AFTER REMOVAL FROM THE PATIENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. THE COMPLAINT PRODUCT WILL BE RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE. THE DEVICE WAS RETURNED FOR ANALYSIS; HOWEVER, THE 50.0 CENTIMETER LONG COIL WAS NOT RETURNED. AS VIEWED INTO THE RETURNED PACKAGING, THE COIL WAS OBSERVED TO HAVE BEEN DETACHED FROM THE DEVICE POSITIONING UNIT (DPU) VIA THE DETACHMENT FIBER. A SEARCH OF THE RETURNED PACKAGING FAILED TO FIND THE SEPARATED COIL. THE COIL WAS ELECTRICALLY DETACHED WHEN THE DETACHMENT BUTTON WAS PRESSED ON THE DETACHMENT CONTROL BOX (DCB). THERE ARE TWO POSSIBLE CONTRIBUTING FACTORS TO THE ABNORMAL RESISTANCE OF THE COIL INSIDE THE MICROCATHETER; HOWEVER WITHOUT THE RETURN OF THE COIL AND THE UNKNOWN MICROCATHETER, IT CANNOT BE DEFINITIVELY DETERMINED. THE EVIDENCE, AS RETURNED, SUGGESTS THAT IF THE DCB¿S DETACHMENT BUTTON WAS PRESSED INSIDE THE INTRODUCER SHEATH OR THE MICROCATHETER THAT THIS MAY HAVE PRODUCED SIGNIFICANT RESISTANCE. IN ADDITION, WITHOUT THE RETURN OF THE DETACHED COIL, IT CANNOT BE DETERMINED IF THIS COMPONENT CONTRIBUTED TO THE COMPLAINT EVENT. THE SECONDARY CONTRIBUTING FACTOR MAY HAVE BEEN DUE TO DISTAL INTERFERENCE INSIDE THE MICROCATHETER. THE SOURCE OF THIS INTERFERENCE; WHETHER OF A FIXED OR DETACHED NATURE CANNOT BE DETERMINED. 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. CONCERNING THE REPORTED STRETCHED COIL; WITHOUT THE RETURN OF THE DETACHED COIL USED IN THE PROCEDURE, THE EXACT ROOT CAUSE THAT PRODUCED THE STRETCHING DAMAGE CANNOT BE DETERMINED. HOWEVER, IT SHOULD BE NOTED THAT THE DPU WAS RETURNED COMPLETELY UNSHEATHED WITH THE RESHEATHING TOOL OVER THE PROXIMAL END OF THE GREEN INTRODUCER. WITH THE GREEN INTRODUCER NOW PROXIMAL TO THE RHV, THIS CONDITION WOULD HAVE ALLOWED THE COIL TO COME IN CONTACT WITH THE ADJUSTABLE RUBBER GASKET INSIDE THE RHV. THIS CONTACT MAY HAVE CAUSED THE COIL TO BECOME TEMPORARILY ANCHORED AND STRETCH. IF THIS OCCURRED, THEN FOR OPTIMUM PRODUCT PERFORMANCE AND TO PREVENT POTENTIAL COMPLICATIONS, THE IFU RECOMMENDS, ¿¿CAUTION: PULLING THE EXPOSED MICROCOIL THROUGH THE RHV GROMMET MAY DAMAGE THE COIL¿¿ 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 COIL UNRAVELING COULD NOT BE CONFIRMED SINCE THE ACTUAL COIL WAS NOT RETURNED FOR ANALYSIS. THE ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, PROCEDURAL/HANDLING FACTORS ADDRESSING IN THE IFU OR INTERACTION WITH THE MICROCATHETER MAY HAVE CONTRIBUTED TO THE EVENT. IT WAS REPORTED THAT THE COIL WAS DETACHED AFTER REMOVAL FROM THE PATIENT. SINCE THERE WAS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THE COIL STRETCHING, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING COIL EMBOLIZATION OF A SPLENIC ARTERY ANEURYSM, AS THE PHYSICIAN WAS POSITIONING A PRESIDIO COIL (PC182050-30/C24508) THROUGH A NON-CODMAN MICROCATHETER, IT FELT ABNORMAL, AND AFTER SAFELY REMOVING THE COIL FROM THE PATIENT, THE COIL WAS FOUND TO BE STRETCHED/UNRAVELLED. THIS WAS THE FIRST COIL USED. THE PHYSICIAN USED A NEW PRESIDIO COIL (LOT UNKNOWN) AND A CASHMERE COIL (LOT UNKNOWN) TO SUCCESSFULLY COMPLETE THE PROCEDURE USING THE SAME MICROCATHETER WITH NO PATIENT INJURY/COMPLICATIONS REPORTED. THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND A CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. PRIOR TO USE, NO DEFECT (KINK, BENDS, ETC.) WAS NOTED ON THE PRODUCTS BY VISUAL INSPECTION, AND THERE HAD BEEN NO REPORTED DIFFICULTY WHILE UNZIPPING THE DEVICE, OR RESISTANCE FRICTION BETWEEN THE DEVICE AND THE MICROCATHETER. ALSO NO DAMAGES WERE REPORTED ON THE DEVICES AFTER THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. THE COMPLAINT PRODUCT WILL BE RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427782 PRESIDIO 18 - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA C24508

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR