BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAMAXX - CERECYTE MICROCOIL

    MDR report key: 4670825 · Received April 9, 2015

    Report

    Report Number
    2954740-2015-00085
    Event Type
    Malfunction
    Date Received
    April 9, 2015
    Date of Event
    March 12, 2015
    Report Date
    March 16, 2015
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K120274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: AN AQUA (CORDIS, 0.018¿, LOT UNKNOWN), A FLEXOR ANSEL (COOK INC., 5FR), A PROGREAT (TERUMO, 0.018¿), AND A GOODTEC Y-CONNECTOR (GOODMAN, TYPE UNKNOWN) WERE USED FOR THIS PROCEDURE. INFORMATION REGARDING PATIENT AGE, GENDER, MEDICATIONS AND WEIGHT WERE NOT AVAILABLE. COMPLAINT CONCLUSION: THE DEVICE WAS RETURNED FOR ANALYSIS. THE COIL WAS RECEIVED UNDAMAGED. THE DETACHMENT FIBER WAS STILL INTACT AND DID NOT RECEIVE HEAT AND MELT. THE DEVICE POSITIONING UNIT (DPU) PASSED ELECTRICAL TESTING WITH RESISTANCE AT 53.0 OHMS AND THE ENPOWER SYSTEMS GO GREEN LIGHT ILLUMINATED. THE COIL DETACHED ON THE FIRST DETACHMENT CYCLE. THE POST-DETACHMENT RESISTANCE PASSES AT 53.6 OHMS. POST-DETACHMENT FOUND THAT THE DETACHMENT FIBER RECEIVED HEAT AND MELTED AS DESIGNED RELEASING THE COIL. NO MANUFACTURING DEFECTS WERE FOUND. LABORATORY TESTING COULD NOT DUPLICATE THE FIELD COMPLAINT; THEREFORE, THE ROOT CAUSE OF THE COILS NON-DETACHMENT INSIDE THE ANEURYSM DURING THE PROCEDURE COULD NOT BE DETERMINED. IN ADDITION, WITHOUT THE IDENTIFICATION OR THE RETURN OF BOTH THE UNKNOWN DETACHMENT CONTROL BOX (DCB), THE CONNECTING CABLE, AND THE UNIDENTIFIED MICROCATHETER 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. THE INABILITY TO DETACH THE COIL COULD NOT BE CONFIRMED THROUGH PRODUCT ANALYSIS. DURING THE ANALYSIS, THE DEVICE FUNCTIONED AS INTENDED WITH DETACHMENT ACHIEVED AFTER THE FIRST ATTEMPT TO DETACH. SINCE THE DEVICE PASSED FUNCTIONAL TESTING, AND THERE WERE NO MANUFACTURING DEFECTS FOUND, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THIS IS AN INITIAL/FINAL MDR.

    Description of Event or Problem · 1

    DURING COIL EMBOLIZATION OF A SPHENOPALATINE ARTERY ANEURYSM, ALTHOUGH THE PRE-DETACHMENT ELECTRICAL CHECK WAS CONDUCTED AND ILLUMINATION OF THE GREEN SYSTEM READY LIGHT WAS CONFIRMED, THE PHYSICIAN WAS UNABLE TO DETACH THE DELTAMAXX (CDX181445-30 / C30469) DESPITE PRESSING THE DETACH BUTTON NUMEROUS TIMES. SINCE THE DELTAMAXX WAS INTENDED AS THE FILLING COIL, THERE WAS A POSSIBILITY OF DISLODGING THE ALREADY-IMPLANTED COIL MASS AND UNRAVELLING OF THE MICROCOIL. NEVERTHELESS, THE DELTAMAXX WAS SUCCESSFULLY RE-SHEATHED WITHOUT AN ISSUE. ANOTHER DELTAMAXX (DIFFERENT LOT NUMBER) WAS THEN INSERTED INSTEAD, WHICH WAS SUCCESSFULLY DETACHED. THE PROCEDURE WAS COMPLETED USING THE SAME CABLE AND DCB WITHOUT FURTHER ISSUES. THERE WERE NO PATIENT INJURY/COMPLICATIONS. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. THERE HAD BEEN NO DIFFICULTY ATTACHING THE COIL TO THE CABLE, AND THERE WAS NO RESISTANCE FELT WHEN ADVANCING THE DEVICE. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCT PRIOR TO THE EVENT AND NO COIL DAMAGE WAS NOTED AFTER THE EVENT. NO INFORMATION WAS AVAILABLE TO CONFIRM IF THE LIGHTS ILLUMINATED WHEN THE POWER BUTTON WAS PRESSED TO ATTEMPT TO DEPLOY THE COIL. THE PATIENT¿S DETAILS SUCH AS SEX, DOB, AND THE TORTUOSITY AND CALCIFICATION LEVEL OF THE VESSELS WERE NOT AVAILABLE. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237133 DELTAMAXX - CERECYTE MICROCOIL CNV DCS COILS HCG CODMAN AND SHURTLEFF, INC C30469

    Patients

    Seq Age Sex Outcome Treatment
    1