BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL PUSHABLE COILS

    MDR report key: 4549147 · Received February 26, 2015

    Report

    Report Number
    1058196-2015-00047
    Event Type
    Malfunction
    Date Received
    February 26, 2015
    Date of Event
    January 31, 2015
    Report Date
    February 2, 2015
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K983483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: A TRANSIT 2 ((B)(4)), SUPERSHEATH (MEDIKIT, 7FR/25CM), A TORCON KMP (COOK INC., 5FR TYPE), AND AN ENPOWER DCB / CABLE (LOTS UNKNOWN) WERE ALSO USED FOR THIS PROCEDURE. COMPLAINT CONCLUSION: THE TRUFILL COIL WAS RECEIVED STUCK INTO THE MICROCATHETER IN A COMPRESSED SECTION OF THE MICROCATHETER. IT WAS REMOVED FROM THE MICROCATHETER; HOWEVER; IT CAME OUT STRETCHED DUE TO THE COMPRESSED SECTION IN THE DISTAL END TIP OF THE MICROCATHETER. THE COIL WAS INSPECTED UNDER A MICROSCOPE, AND IT WAS FOUND STRETCHED. THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE DEVICES RECEIVED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE COIL BEING STUCK IN THE MICROCATHETER WAS CONFIRMED DURING FUNCTIONAL ANALYSIS. THE ROOT CAUSE OF THE COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, THE CONDITION OF THE COIL WAS APPARENTLY CAUSED BY THE MICROCATHETER COMPRESSION FOUND DURING ANALYSIS. IT CANNOT BE DETERMINED IF THE COMPRESSION OCCURRED DURING THE PROCEDURE OR DURING POST-PROCEDURAL HANDLING OF THE DEVICE. HOWEVER, THESE DEFECTS COULD NOT BE RELATED TO THE MANUFACTURING PROCESS, AND PROCEDURAL/ HANDLING FACTORS APPEAR TO HAVE CONTRIBUTED TO THE DAMAGE FOUND DURING ANALYSIS. NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THE FAILURE REPORTED COULD BE RELATED TO THE MANUFACTURING PROCESS. ADDITIONALLY INSPECTIONS ARE IN PLACE AS THAT PREVENTS THESE KINDS OF FAILURES FROM LEAVING THE MANUFACTURING FACILITY. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THIS IS AN INITIAL/FINAL MDR. THIS IS 1 OF 2 MDRS SUBMITTED FOR THIS COMPLAINT WITH ASSOCIATED MANUFACTURE REPORT NUMBERS OF 1058196-2015-00046 AND 1058196-2015-00047.

    Description of Event or Problem · 1

    DURING COIL EMBOLIZATION OF THE PATIENT¿S IIA, IT WAS REPORTED THAT THE TRUFILL ((B)(4)) WAS STUCK AT 0.4CM FROM THE DISTAL TIP OF THE TRANSIT 2 ((B)(4)) WHEN THE TRUFILL WAS INSERTED BY USING THE 2.5ML SYRINGE BY UNSPECIFIED MANUFACTURER. THE COIL BECAME STUCK AFTER THE LUMEN OF THE MICROCATHETER WAS FLUSHED. PRIOR TO THE EVENT, A PRESIDIO 18 AND A DELTAMAXX HAD BEEN INSERTED WITHOUT FRICTION. THE PHYSICIAN USED A TRUPUSH, WHICH HE STATED THAT WE WOULD NOT NORMALLY USE TO PUSH OUT THE COIL, BUT COULD NOT RETRIEVE THE COIL. THE TRUFILL AND THE TRANSIT WERE SAFELY REMOVED TOGETHER FROM THE PATIENT, AND ANOTHER MICROCATHETER WAS INSERTED TO CONTINUE THE PROCEDURE. THERE WAS NO VISIBLE DAMAGE TO EITHER OF THE PRODUCTS. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES, HOWEVER DUE TO THE EVENT THERE WAS ABOUT 10 MINUTES DELAY. THERE WERE NO PATIENT INJURY/COMPLICATIONS. THE COMPLAINT PRODUCTS WERE 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. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO THE EVENTS. THE MICROCATHETER HAD NOT BEEN RESHAPED. IT WAS REPORTED THAT THE PATIENT VESSELS WERE MODERATELY TORTUOUS AND MILDLY CALCIFIED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135414 TRUFILL PUSHABLE COILS CNV_PUSHABLE COILS (MCG) HCG CODMAN AND SHURTLEFF, INC 17012390

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR