BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERLOCK¿-35

    MDR report key: 2613236 · Received June 12, 2012

    Report

    Report Number
    2134265-2012-03833
    Event Type
    Injury
    Date Received
    June 12, 2012
    Date of Event
    May 14, 2012
    Report Date
    May 14, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K110295
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: ONE DELIVERY WIRE AND COIL WERE RECEIVED. THE DELIVERY WIRE WAS KINKED IN TWO PLACES. THE COIL WAS SEVERELY STRETCHED. THE INTERLOCKING ARM HAD BEEN PULLED OFF THE COIL AND THERE WAS EVIDENCE OF A WELD. DRIED BLOOD WAS OBSERVED ON THE COIL. THE INTERLOCKING ARM OF THE DELIVERY WIRE WAS INSPECTED AND NO DAMAGE WAS NOTED. THE ZAP TIP SHAPE AND SURFACE OF THE DELIVERY WIRE WAS SMOOTH. THE INTERLOCKING ARM OF THE COIL WAS NOT PRESENT. THE ZAP TIP SHAPE AND SURFACE OF THE COIL WAS SMOOTH AND SLIGHTLY STRETCHED. THE DELIVER WIRE DIMENSIONS WERE FOUND TO BE IN SPECIFICATION. AS THE COIL WAS DAMAGED NOT ALL DIMENSIONS COULD BE MEASURED. THE COIL DIMENSIONS THAT COULD BE MEASURED WERE FOUND TO BE IN SPECIFICATION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED USER RELATED AS CONTINUOUS FLUSH WAS NOT MAINTAINED AND AN INCORRECT CATHETER WAS USED PER THE DFU. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT PROCEDURE, COIL MIGRATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS COLLATERAL OF THE RIGHT INTERNAL MAMMARY ARTERY (RIMA). A 035 4MM X 20CM IDC INTERLOCK COIL WAS ADVANCED INTO THE PATIENT AND RESISTANCE WAS ENCOUNTERED. THE COIL WAS REMOVED SUCCESSFULLY. A 4F .035 NON-BSC CATHETER WAS PLACED AND ANOTHER 035 4MM X 20CM IDC INTERLOCK COIL WAS ADVANCED THROUGH THE CATHETER. DURING ADVANCEMENT, THE INTERLOCKING ARM DETACHED. A NON-BSC SNARE WAS UTILIZED TO SUCCESSFULLY REMOVE THE COIL. THE COIL WAS GREATLY STRETCHED AND ELONGATED. THE COIL WAS PULLED BACK TO THE END OF THE CATHETER AND THE CATHETER WAS CUT. THE REST OF THE CATHETER WAS REMOVED AND NO OTHER COILS WERE DEPLOYED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT PROCEDURE, COIL MIGRATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS COLLATERAL OF THE RIGHT INTERNAL MAMMARY ARTERY (RIMA). A 035 4MM X 20CM IDC INTERLOCK COIL WAS ADVANCED INTO THE PATIENT AND RESISTANCE WAS ENCOUNTERED. THE COIL WAS REMOVED SUCCESSFULLY. A 4F .035 NON-BSC CATHETER WAS PLACED AND ANOTHER 035 4MM X 20CM IDC INTERLOCK COIL WAS ADVANCED THROUGH THE CATHETER. DURING ADVANCEMENT, THE INTERLOCKING ARM DETACHED. A NON-BSC SNARE WAS UTILIZED TO SUCCESSFULLY REMOVE THE COIL. THE COIL WAS GREATLY STRETCHED AND ELONGATED. THE COIL WAS PULLED BACK TO THE END OF THE CATHETER AND THE CATHETER WAS CUT. THE REST OF THE CATHETER WAS REMOVED AND NO OTHER COILS WERE DEPLOYED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLOCK¿-35 DEVICE, EMBOLIZATION, VASCULAR KRD BOSTON SCIENTIFIC - CORK M001363530 14963523

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention