BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRE SINGLE ELECTRODE PROBE

    MDR report key: 1690036 · Received May 7, 2010

    Report

    Report Number
    1319211-2010-00020
    Event Type
    Malfunction
    Date Received
    May 7, 2010
    Date of Event
    March 24, 2010
    Report Date
    May 4, 2010
    Manufacturer
    ANGIODYNAMICS
    Product Code
    OHJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: BASED ON THE REPORTED COMPLAINT, IT APPEARS AS IF THE IRE PROBES PERFORMED AS INTENDED, BUT DURING THE PROCEDURE, THE PROBES MOVED. THE EXACT CAUSE OF THE COMPLAINT APPEARS TO BE DESIGN RELATED. IT IS POSSIBLE THE MOVEMENT OF THE PROBES WAS CAUSED DUE TO RESPIRATION OR CABLE WEIGHT. CURRENTLY THERE IS NOTHING IN THE DESIGN TO PREVENT THE PROBES FROM MOVING. MANUFACTURING AND PRODUCT DEVELOPMENT HAVE BEEN MADE AWARE TO THIS COMPLAINT. DURING THE REVIEW OF THE MANUFACTURING RECORDS FOR THE POSSIBLE LOTS, IT WAS OBSERVED THAT THE MANUFACTURED LOTS MEET ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS. THIS TYPE OF COMPLAINT IS BEING EVALUATED BY OUR ENGINEERING GROUP. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. NO FURTHER ACTION REQUIRED AT THIS TIME. FREQUENCY HAS INCREASED BUT THE SEVERITY OF THE EVENT IS NOT GREATER THAN USUAL.

    Description of Event or Problem · 1

    TREATED OUR 9TH PT WITH IRE TODAY. PT HAD (B)(6) INDUCED CIRRHOSIS, A 2 CM HCC AND IS CURRENTLY DOING WELL. HOWEVER, DURING THE COURSE OF THE TREATMENT, SEVERAL PROBES MOVED DEEPER BY 4-6 CM DESPITE CLOSE OBSERVATION. NO DEFINITE COMPLICATIONS OF THE MULTIPLE PROBE MIGRATIONS ARE CURRENTLY APPARENT. WILL CONTINUE TO OBSERVE. THIS PROBE MOTION DEEPER INTO THE LIVER OCCURRED SEVERAL TIMES AND WAS OBSERVED BY CLINICAL APPLICATIONS SPECIALIST. AS I MENTIONED, THIS INABILITY TO LOCK THE PROBES IN PLACE COULD LEAD TO EVEN MORE SERIOUS COMPLICATIONS. WHILE IRE DOES NOT INJURE COLLAGEN OR ELASTIN, THERE CAN BE MECHANICAL INJURY, THE PROBES COULD MOVE DEEPER OR MOVE OUT. POTENTIALLY LEADING TO LACERATIONS OF DELICATE OR VITAL STRUCTURES SUCH AS BILE DUCTS, URETERS, BOWEL, DIAPHRAGM, LUNG, OR VESSELS. IT ALSO MAKES THE TREATMENT AREAS UNRELIABLE SINCE THE PROBES MOVE DURING THE PULSES. THIS COULD LEAD TO UNTREATED AREAS. A SPACER IS NOT AN ANSWER SINCE THE PROBES CAN MOVE OUT AND SINCE THE SPACE WOULD NEED TO BE VARIABLE. THE NEEDLES NEED TO BE FIXED EITHER MECHANICALLY WITH TINES OR FROZEN AS PER (B)(4) WITH CO2. NO CARDIAC ISSUES WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IRE SINGLE ELECTRODE PROBE IRE SINGLE ELECTRODE PROBE OHJ ANGIODYNAMICS NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention