BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR¿

    MDR report key: 2943335 · Received February 5, 2013

    Report

    Report Number
    3005099803-2013-00364
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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. NO HAIR WAS FOUND INSIDE THE RETURNED SENSOR GUIDEWIRE PACKAGING. THE PACKAGE WAS RETURNED OPENED AND NO HAIR WAS FOUND INSIDE, INSTEAD, A YELLOW SPOT APPEARED AT ONE SIDE, AS EVIDENCE OF HANDLING. THE ENTIRE LENGTH OF THE WIRE WAS EXAMINED AND NO ANOMALIES WERE OBSERVED. TAKING INTO CONSIDERATION THESE FACTORS A PROBABLE ROOT CAUSE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HAIR WAS NOTICED INSIDE THE PRODUCT PACKAGING OF A SENSOR GUIDEWIRE. REPORTEDLY, THE HAIR WAS INSIDE THE STERILE PACKAGING, AND WAS NOTICED DURING PREPARATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT HARM TO THE PATIENT, WHOSE CONDITION AT THE CONCLUSION OF THIS PROCEDURE WAS "FINE."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HAIR WAS NOTICED INSIDE THE PRODUCT PACKAGING OF A SENSOR GUIDEWIRE. REPORTEDLY, THE HAIR WAS INSIDE THE STERILE PACKAGING, AND WAS NOTICED DURING PREPARATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT HARM TO THE PATIENT, WHOSE CONDITION AT THE CONCLUSION OF THIS PROCEDURE WAS 'FINE.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49355 SENSOR¿ STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0066703081 15622164

    Patients

    Seq Age Sex Outcome Treatment
    1