BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR?

    MDR report key: 3170279 · Received June 14, 2013

    Report

    Report Number
    3005099803-2013-05030
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. VISUAL INSPECTION WAS PERFORMED. THE ENTIRE LENGTH OF THE WIRE WAS EXAMINED AND ANOMALIES WERE OBSERVED. IT WAS OBSERVED THE COATING PEELED AT DISTAL END AND THE DISTAL TIP PEELING EXPOSING THE CORE WIRE. BASED ON ALL GATHERED INFORMATION, NO FURTHER ACTIONS ARE CONSIDERED NECESSARY. THE MOST PROBABLE ROOT CAUSE IS: OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    THE EVENT, AS REPORTED, DOES NOT CONSTITUTE AN MDR REPORTABLE EVENT; HOWEVER, THE RETURNED DEVICE REVEALED AN MDR REPORTABLE EVENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSOR WIRE WAS USED DURING A GASTROSTOMY ON (B)(6) 2013. THE COMPLAINANT STATES THAT DURING THE PROCEDURE A SENSOR GUIDEWIRE WAS USED INSTEAD OF STANDARD GUIDEWIRE INCLUDED IN THE PACKAGE. ACCORDING TO THE PHYSICIAN, RESISTANCE WAS MET UPON REMOVING THE GUIDEWIRE FROM THE BODY AND HE WAS THEN USING A COLOPLAST'S NEPHROSTOMY CATHETER KIT. THE PHYSICIAN TRIED REMOVING THE GUIDEWIRE THUS, COATING MATERIAL OF DISTAL TIP WAS PEELED OFF, DETACHED AND REMAINED IN THE RENAL PELVIS. A PERCUTANEOUS NEPHRO LITHOTRIPSY WAS PERFORMED IN ORDER TO REMOVE THE DETACHED COATING FRAGMENT BUT IT WAS NOT SUCCESSFUL. A SECOND TRIAL WAS DONE ON (B)(6) 2013, TO REMOVE THE FRAGMENT AND RESULTS HAS NOT BEEN OBTAINED YET. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271630 SENSOR? STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0066703051

    Patients

    Seq Age Sex Outcome Treatment
    1