BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR¿

    MDR report key: 2871633 · Received December 13, 2012

    Report

    Report Number
    3005099803-2012-05709
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 21, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF GUIDEWIRE TIP DETACHED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING-RELATED POTENTIAL CAUSE FOR THIS EVENT. ANALYSIS OF THE RETURNED SENSOR GUIDEWIRE REVEALED THAT THE URETHANE TIP HAD DETACHED, EXPOSING THE CORE WIRE. MOST LIKELY, UNSTATED PROCEDURE AND POSSIBLY CLINICAL FACTORS CONTRIBUTED TO THE URETHANE TIP DETACHMENT, INCLUDING BUT NOT LIMITED TO INTERACTION WITH OTHER DEVICES, HANDLING OF THE DEVICE AND CONDITION OF THE TREATED LESION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DIFFICULTY WAS EXPERIENCED INSERTING THE SENSOR GUIDEWIRE INTO THE PATIENT, DURING A URETEROSCOPY PROCEDURE. UPON REMOVING THE GUIDEWIRE FROM THE PATIENT, THE BLACK TIP OF THE WIRE WAS NOTICED TO BE DETACHED. THE BLACK PORTION OF THE WIRE WAS VISUALIZED IN THE PATIENT AND REMOVED. REPORTEDLY, THE CORE WIRE REMAINED INTACT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "STABLE." SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL PATIENT AND EVENT INFORMATION. HOWEVER, NO FURTHER EVENT DETAILS HAVE BEEN MADE AVAILABLE TO BOSTON SCIENTIFIC TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DIFFICULTY WAS EXPERIENCED INSERTING THE SENSOR GUIDEWIRE INTO THE PATIENT, DURING A URETEROSCOPY PROCEDURE. UPON REMOVING THE GUIDEWIRE FROM THE PATIENT, THE BLACK TIP OF THE WIRE WAS NOTICED TO BE DETACHED. THE BLACK PORTION OF THE WIRE WAS VISUALIZED IN THE PATIENT AND REMOVED. REPORTEDLY, THE CORE WIRE REMAINED INTACT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "STABLE". SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL PATIENT AND EVENT INFORMATION. HOWEVER, NO FURTHER EVENT DETAILS HAVE BEEN MADE AVAILABLE TO BOSTON SCIENTIFIC TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSOR¿ STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0066703081 15489100

    Patients

    Seq Age Sex Outcome Treatment
    1