BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAVI APPLICATOR

    MDR report key: 1250203 · Received September 4, 2008

    Report

    Report Number
    2032338-2008-00001
    Event Type
    Malfunction
    Date Received
    September 4, 2008
    Date of Event
    June 11, 2008
    Report Date
    August 12, 2008
    Manufacturer
    CIANNA MEDICAL
    Product Code
    MIJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE DEVICE, AN ENGINEERING EVAL WAS CONDUCTED AND THE FOLLOWING WAS OBSERVED: MACROSCOPIC EVAL: THE CATHETER #6 STRUT ASSEMBLY WAS INVERTED. THE REMAINING CATHETERS WERE IN THE EXPANDED POSITION IN A SYMMETRICAL PATTERN. THE DISTAL SHAFT OF THE APPLICATOR SHOWED A SLIGHT BEND. THE EXPANSION TOOL WAS SEATED AGAINST THE MAKE/HEXAGONAL FORMED FEATURE AT THE PROXIMAL END OF THE ACTUATING SCREW AND ROTATED COUNTER CLOCKWISE. THE STRUTS COLLAPSED WITHOUT OBSTRUCTIONS UNTIL THE HARD STOP IN THE LEAD SCREW MECHANISM WAS REACHED INDICATING THE FULLY COLLAPSED POSITION OF THE APPLICATOR STRUTS. SUBSEQUENTLY, THE EXPANSION TOOL WAS ROTATED CLOCKWISE TO EXPAND THE STRUTS TO THE MAXIMUM EXPANDED DIAMETER. AGAIN, THE APPLICATOR EXPANDED SMOOTHLY UNTIL THE AUDIBLE CLICK WAS REACHED. CATHETER #6 REMAINED IN ITS INVERTED POSITION. THE APPLICATOR WAS THEN DECONTAMINATED AND CATHETER #6 WAS READJUSTED INTO A STRAIGHT POSITION AND THE APPLICATOR CYCLED 3 ADD'L TIMES WITHOUT ENCOUNTERING ANY OBSTRUCTIONS. CONCLUSION: THE LEAD SCREW MECHANISM THAT SERVES TO EXPAND AND COLLAPSE THE APPLICATOR WORKED APPROPRIATELY. THE ACTUATION WAS SMOOTH AND THE POSITION INDICATORS (HARD STOP AND CLICK) FUNCTIONED AS DESIGNED. SPLAYED STRUTS CAN OCCUR WHEN THE LUMPECTOMY CAVITY IS FIBROTIC AND IS ATTRIBUTABLE TO CAVITY AGE AND SIZE. IT IS POSSIBLE THAT THE EXPANSION TOOL WAS NOT PROPERLY ENGAGED DURING THE COLLAPSING OF THE DEVICE. THERE WAS NO OBSERVED DEVICE MALFUNCTION AND NO FURTHER REPORTING WAS INDICATED. THIS INFO IS BEING PROVIDED BASED ON ADD'L INFO REC'D VIA USER FACILITY REPORT.

    Description of Event or Problem · 1

    SUBSEQUENT TO PLACEMENT OF THE SAVI DEVICE, CT IMAGING REVEALED AN INVERTED OR SPLAYED STRUT. FURTHER EXPANSION OF THE DEVICE WAS PERFORMED AND ADD'L CT IMAGING SHOWED THAT 4 STRUTS WERE EXPANDED NORMALLY AND THAT 4 STRUTS WERE SPLAYED. THE DECISION WAS MADE TO REMOVE THE DEVICE. THE DEVICE WAS COLLAPSED AND THE DEVICE WAS REMOVED, HOWEVER, UPON REMOVAL, IT WAS OBSERVED THAT THE DEVICE WAS NOT COMPLETELY COLLAPSED, CAUSING DISCOMFORT TO THE PT. THE INCISION SITE WAS CLOSED WITH NO SEQUELAE. PT WAS SUBSEQUENTLY REFERRED FOR OTHER RADIATION THERAPIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAVI APPLICATOR RADIO-NUCLIDE APPLICATOR MIJ CIANNA MEDICAL RTK-08 NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention