BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRUSPHERE 10 - CERECYTE MICROCOIL

    MDR report key: 4201619 · Received October 27, 2014

    Report

    Report Number
    2954740-2014-50020
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 30, 2014
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K0022420
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: EXCELSIOR SL-10 MICROCATHETER (STRYKER, TYPE UNKNOWN). ENPOWER DETACHMENT CONTROL BOX (LOT UNKNOWN). ENPOWER CONTROL CABLE (LOT UNKNOWN). ANOTHER MICRUSPHERE COIL (DETAILS UNKNOWN). 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 IS AVAILABLE FOR EVALUATION AND TESTING, HOWEVER THE ANALYSIS HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. NO CONCLUSIONS ARE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    MANUFACTURE DATE AND EXPIRATION DATES WERE NOT INCLUDED IN THE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT COIL WAS RETURNED. LIMITED INFORMATION WAS RECEIVED. BOTH THE UNIDENTIFIED (PER LOT #) DCB AND CONNECTING CABLE WERE NOT RETURNED WITH THE MICROCOIL SYSTEM. THE SL-10 MICROCATHETER WAS NOT RETURNED. CONCERNING CLEANLINESS ONLY, THE MICROCOIL SYSTEM WAS RETURNED IN ALMOST PRISTINE CONDITION. THE SYSTEM WAS EITHER NOT USED OR WAS CLEANED/RINSED BEFORE BEING RETURNED WHICH MAY HAVE PRODUCED FURTHER DAMAGE. IT IS ALSO UNKNOWN IF THE DEVICE WAS FURTHER MANIPULATED AND/OR INSPECTED POST-PROCEDURALLY. ANY TRACE EVIDENCE THAT MAY HAVE BEEN COMPLAINT RELATED MAY HAVE BEEN ALTERED OR REMOVED PRIOR TO BEING RETURNED. AS VIEWED THROUGH THE RETURNED PACKAGING, IT WAS OBSERVED THAT THE COIL WAS RETURNED UNSHEATHED AND DAMAGED. THE COIL WAS RETURNED DAMAGED RESULTING IN A PARTIAL LOSS OF THE SECONDARY WINDING SHAPE. THE COIL¿S SOCKET RING HAS BEEN PUSHED DOWN UNDER THE OUTER SHEATH (ANGLE RING SECTION). LOCATED AT THE DISTAL TIP OF THE STRAIN RELIEF THE CORE WIRE HAS BEEN SEVERELY KINKED. THE TIME FRAME AND CIRCUMSTANCES OF HOW AND WHEN THE ABOVE DAMAGE OCCURRED TO THE COIL AND CORE WIRE CANNOT BE DETERMINED AS IT WAS REPORTED IN THE COMPLAINT EVENT THAT THE DEVICE WAS NOT DAMAGED. TENSION WAS APPLIED TO THE DETACHMENT FIBER TO VERIFY THAT THE FIBER DID NOT RECEIVE HEAT AND MELT. UPON RECEIPT, THE DEVICE POSITIONING UNIT (DPU) PASSED ELECTRICAL TESTING WITH RESISTANCE AT 52.0 AND THE ENPOWER SYSTEMS GO GREEN LIGHT ILLUMINATED. THE COIL WAS THEN DETACHED ON THE FIRST DETACHMENT CYCLE. POST-DETACHMENT RESISTANCE PASSED AT 52.1 OHMS. THE DETACHMENT FIBER RECEIVED HEAT AND MELTED AS DESIGNED RELEASING THE COIL; THEREFORE, THE ROOT CAUSE OF THE COILS NON-DETACHMENT INSIDE THE ANEURYSM CANNOT BE DETERMINED. IN ADDITION, WITHOUT THE RETURN OF THE COMPLETE DETACHMENT SYSTEM AND THE SL-10 MICROCATHETER USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS HAD ANY CONTRIBUTIONS 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 INFORMATION AND ANALYSIS, THE EVENT WAS NOT CONFIRMED. THE RETURNED PRODUCT PASSED TESTING AND 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. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING EMBOLIZATION OF AN ANEURYSM AT THE PATIENT¿S ANTERIOR COMMUNICATING ARTERY THE MICRUSPHERE COIL ((B)(4)) COULD NOT BE DETACHED. THE ARTERY WAS NOT TORTUOUS AND NOT CALCIFIED. IT WAS REPORTED THAT AN EXCELSIOR SL-10 MICROCATHETER (STRYKER, TYPE UNKNOWN), AN ENPOWER DETACHMENT CONTROL BOX (LOT UNKNOWN), AND AN ENPOWER CONTROL CABLE (LOT UNKNOWN) WERE ALSO USED FOR THE ABOVE PROCEDURE. NO FURTHER DETAILS OF THE CONCOMITANT DEVICES ARE AVAILABLE. THE COMPLAINT COIL WAS INTENDED TO BE USED AS THE FRAMING COIL. AFTER THE COMPLAINT COIL WAS PLACED IN THE TARGET ANEURYSM, THE PHYSICIAN PRESSED THE DETACH BUTTON OF THE CONTROL CABLE. HOWEVER, WHEN THE PHYSICIAN WAS WITHDRAWING THE COMPLAINT COIL¿S DELIVERY SYSTEM, HE FOUND OUT THAT THE COIL WAS UNDETACHED. THE PHYSICIAN PRESSED THE DETACH BUTTON SEVERAL TIMES, BUT NO AVAIL. THE COMPLAINT COIL WAS WITHDRAWN AND REPLACED WITH ANOTHER MICRUSPHERE (DETAILS UNKNOWN), WHICH WAS SUCCESSFULLY DETACHED ON THE FIRST ATTEMPT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES. HOWEVER, DUE TO THE EVENT IT WAS DELAYED FOR 10 MINUTES. THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. PRIOR TO USE, NO DEFECT (KINK, BENDS, ETC.) WAS NOTED ON THE PRODUCT BY VISUAL INSPECTION. ALSO NO DAMAGES WERE REPORTED ON THE DEVICES AFTER THE EVENT. THERE WAS NO STRETCHING OR UNINTENDED DETACHMENT OF THE COIL OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED BUT THE RESULTS ARE NOT PROVIDED. THERE WAS NO ABNORMAL BEHAVIOR OR FAULT LIGHTS PRIOR TO PRESSING THE DETACH BUTTON. THERE WAS NO MISHANDLING OF THE DEVICES AND THE CABLES WERE CONNECTED WITHOUT APPLYING EXCESSIVE FORCE. THE COMPLAINT PRODUCT WILL BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682034 MICRUSPHERE 10 - CERECYTE MICROCOIL CNV DCS COILS HCG CODMAN AND SHURTLEFF, INC C23348

    Patients

    Seq Age Sex Outcome Treatment
    1