BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR?

    MDR report key: 3090514 · Received May 2, 2013

    Report

    Report Number
    3005099803-2013-03055
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL ANALYSIS OF THE RETURNED SENSOR GUIDEWIRE REVEALED THAT THE DISTAL TIP OF THE WIRE WAS ELONGATED, EXPOSING THE CORE WIRE. THE CORE WIRE WAS BROKEN. ADDITIONALLY, THE COATING HAD PEELED FROM THE WIRE AND THE URETHANE TIP ON THE DISTAL END WAS NOT PRESENT WITH THE RETURN. FURTHER ANALYSIS HAS CONCLUDED THAT THE WIRE BROKE AS A RESULT OF REVERSE CYCLIC BENDING WITH FINAL TENSION OVERLOAD. MOST LIKELY, DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE WAS LIMITED AND MAY HAVE CONTRIBUTED TO THE FAILURE. BASED ON ALL GATHERED INFORMATION, ¿OPERATIONAL CONTEXT¿ OF THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A URETEROSCOPY PROCEDURE, USING A SENSOR GUIDEWIRE PERCUTANEOUSLY, THE GUIDEWIRE REPORTEDLY DETACHED BETWEEN THE SKIN SURFACE AND KIDNEY DURING THE DILATING PHASE OF THE PROCEDURE. THE DETACHMENT WAS IMMEDIATELY NOTICED AND BOTH PIECES WERE REMOVED FROM THE PATIENT, USING REUSABLE FORCEPS WITHOUT COMPLICATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE, WITH NO COMPLICATIONS TO THE PATIENT, WHOSE CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTEDLY "STABLE."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A URETEROSCOPY PROCEDURE, USING A SENSOR GUIDEWIRE PERCUTANEOUSLY, THE GUIDEWIRE REPORTEDLY DETACHED BETWEEN THE SKIN SURFACE AND KIDNEY DURING THE DILATING PHASE OF THE PROCEDURE. THE DETACHMENT WAS IMMEDIATELY NOTICED AND BOTH PIECES WERE REMOVED FROM THE PATIENT, USING REUSABLE FORCEPS WITHOUT COMPLICATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE, WITH NO COMPLICATIONS TO THE PATIENT, WHOSE CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTEDLY ¿STABLE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193062 SENSOR? STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - MARLBOROUGH M0066703081 15760179

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention