BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSUREWIRE CERTUS

    MDR report key: 2554381 · Received May 28, 2010

    Report

    Report Number
    8030904-2010-00002
    Event Type
    Malfunction
    Date Received
    May 28, 2010
    Date of Event
    May 30, 2010
    Report Date
    April 28, 2010
    Manufacturer
    RADI MEDICAL SYSTEMS AB
    Product Code
    DXO
    PMA / PMN Number
    K080813
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE EVENT DESCRIPTION ((B)(4)): THE EVENT DESCRIPTION DOES NOT INDICATE THAT THE DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO AN INJURY. EVAL SUMMARY: THE WIRE HAS BEEN EXAMINED UNDER THE MICROSCOPE AND THE SURFACES OF THE BROKEN PARTS HAVE BEEN EXAMINED BY SEM (SCANNING ELECTRON MICROSCOPE) AND IT CAN CLEARLY BE SEEN THAT THE CORE WIRE HAS BEEN EXPOSED TO MUCH TORQUING AND BENDING STRESS UNTIL IT BROKE. NO MATERIAL DEFICIENCIES COULD BE OBSERVED. AS SOON AS THE WIRE WAS INTRODUCED IN THE VESSEL THE SIGNAL WAS LOST. THERE COULD BE SEVERAL REASONS FOR WHY THE SIGNAL WAS LOST. A PROBABLE HYPOTHESIS FOR ROOT CAUSE OF FAILURE THAT RADI MED SYS WILL ACT UPON IS THAT THE COMPLAINT WIRE HAVE BEEN BENT SOMEWHERE IN THE RADI PROCESSING, AND THEN REWORKED BY STRAIGHTENING. A WEAK POINT HAS THEN BEEN INTRODUCED IN THE WIRE AT THE BENDING SITE. THE WIRE HAS BEEN TRAVELED THROUGH FURTHER PROCESSING AND ALL THE WAY TO EQUALIZATION BY THE CUSTOMER. THE FACT THAT THE COMPLAINT WIRE IS ELECTRICALLY INTACT DISTAL AND PROXIMAL TO THE BREAK INDICATE THAT THE WIRE WAS BROKEN ALREADY AT TIME OF EQUALIZATION. THE ROTATION THAT THE COMPLAINT WIRE HAS SEEN REMAINS UNEXPLAINED. IT MAY HAVE HAPPENED AT START OF MANEUVERING AFTER EQUALIZATION.

    Description of Event or Problem · 1

    EVENT DESCRIPTION (FROM VOLUNTARY REPORT NO: (B)(4)): CALIBRATION AND EQUALIZATION PERFORMED OK. WHEN THE WIRE WAS INTRODUCED ONLY A LITTLE BIT IN THE VESSEL THE SIGNAL GOT LOST. TO RESOLVE THE PROBLEM DISCONNECTION AND RECONNECTION WAS PERFORMED, BUT STILL NO SIGNAL. THE PRESSUREWIRE WAS REMOVED FROM THE PT AND PUT ON A BENCH. AFTER THAT WHEN THE NURSE WAS WIPING THE PRESSUREWIRE WITH A CLOTH SOAKED IN SALINE SOLUTION, THE WIRE BROKE APART AT THE JUNCTION FLEXIBLE SECTION/SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSUREWIRE CERTUS TRANSDUCER, PRESSURE, CATHETER TIP DXO RADI MEDICAL SYSTEMS AB 12006 102005C

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other