BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIMA¿

    MDR report key: 2831945 · Received November 14, 2012

    Report

    Report Number
    2134265-2012-07055
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 17, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FFA
    PMA / PMN Number
    K944290
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED AND IT WAS CUT IN MULTIPLE SECTIONS. FUNCTIONAL AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED DUE TO UNIT CONDITION (CUT IN MULTIPLE SECTIONS), ADDITIONALLY THESE SECTIONS WERE RETURNED IN AN ALCOHOL SOLUTION AND ACCORDING WITH THE DFU STATES: "DO NOT ALLOW ALCOHOL TO CONTACT THE CATHETER. EXPOSING THE CATHETER TO ALCOHOL MAY DAMAGE THE COATING AND CATHETER". THE MANUFACTURING BATCH RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS PAIR (PUNCTURE, ASPIRATION, INJECTION, REASPIRATION) TREATMENT PROCEDURE CATHETER BREAKAGE OCCURRED. THE PROCEDURE WAS INDICATED DUE TO THE PRESENCE OF A HYDAID CYST. THE INITIAL PAIR PROCEDURE TREATED AN UNSPECIFIED SEGMENT VII LESION IN THE LIVER. A VTC/10/K FLEXIMA DRAINAGE CATHETER WAS IMPLANTED. THE SECOND PAIR PROCEDURE WAS SCHEDULE; HOWEVER, A LARGE OUTPUT VOLUME OF 500ML OF BROWNISH FLUID WAS NOTED OVER THE PAST 24 HOURS AND THE PREVIOUSLY IMPLANTED FLEXIMA DRAINAGE CATHETER WAS FOUND ALMOST COMPLETELY BROKE AT ITS HEPATIC SEGMENT (10MM IN LENGTH). A FEW MILLILITERS (ML) OF CONTRAST MEDIUM (CM) WAS INJECTED AND A LEAK THROUGH THE BROKEN CATHETER WAS NOTED WITHOUT OPACIFYING THE CYST. A NON-BSC SOFT WIRE WAS ADVANCED PAST THE DAMAGED SEGMENT AND A 4F UNSPECIFIED ANGIO-CATHETER WAS ADVANCED CLOSE TO THE TIP OF THE DRAINAGE CATHETER TO STRAIGHTEN THE CATHETER BEFORE SUCCESSFUL REMOVAL. A NEW 10F FLEXIMA DRAINAGE CATHETER WAS INSERTED TO THE CAVITY OF THE HYDATID CYST AND THE 2ND PAIR PROCEDURE WAS PERFORMED WITH 10% SALINE AND ABSOLUTE ALCOHOL INJECTIONS. 40ML SCOLICID FLUID WAS INJECTED 3 TIMES AND KEP FOR 20-20 MINU; THE 3RD 40 ML WAS KEPT IN THE CYST. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS PAIR (PUNCTURE, ASPIRATION, INJECTION, REASPIRATION) TREATMENT PROCEDURE CATHETER BREAKAGE OCCURRED. THE PROCEDURE WAS INDICATED DUE TO THE PRESENCE OF A HYDAID CYST. THE INITIAL PAIR PROCEDURE TREATED AN UNSPECIFIED SEGMENT VII LESION IN THE LIVER. A VTC/10/K FLEXIMA DRAINAGE CATHETER WAS IMPLANTED. THE SECOND PAIR PROCEDURE WAS SCHEDULE; HOWEVER, A LARGE OUTPUT VOLUME OF 500ML OF BROWNISH FLUID WAS NOTED OVER THE PAST 24 HOURS AND THE PREVIOUSLY IMPLANTED FLEXIMA DRAINAGE CATHETER WAS FOUND ALMOST COMPLETELY BROKEN AT ITS HEPATIC SEGMENT (10MM IN LENGTH). A FEW MILLILITERS (ML) OF CONTRAST MEDIUM (CM) WAS INJECTED AND A LEAK THROUGH THE BROKEN CATHETER WAS NOTED WITHOUT OPACIFYING THE CYST. A NON-BSC SOFT WIRE WAS ADVANCED PAST THE DAMAGED SEGMENT AND A 4F UNSPECIFIED ANGIO-CATHETER WAS ADVANCED CLOSE TO THE TIP OF THE DRAINAGE CATHETER TO STRAIGHTEN THE CATHETER BEFORE SUCCESSFUL REMOVAL. A NEW 10F FLEXIMA DRAINAGE CATHETER WAS INSERTED TO THE CAVITY OF THE HYDATID CYST AND THE 2ND PAIR PROCEDURE WAS PERFORMED WITH 10% SALINE AND ABSOLUTE ALCOHOL INJECTIONS. FORTY (40) ML SCOLICID FLUID WAS INJECTED 3 TIMES AND KEPT FOR 20-20 MINU; THE 3RD 40 ML WAS KEPT IN THE CYST. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA¿ TUBE, DRAINAGE, SUPRAPUBIC FFA BOSTON SCIENTIFIC - COSTA RICA (COYOL) M001271870 14740385

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention