BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MORPHEUS CT PICC

    MDR report key: 957533 · Received April 27, 2007

    Report

    Report Number
    1319211-2007-00012
    Event Type
    Malfunction
    Date Received
    April 27, 2007
    Date of Event
    March 27, 2007
    Report Date
    April 27, 2007
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT HISTORY RECORD REVIEW: THE LOT HISTORY RECORDS WERE REVIEWED FOR ANY ABNORMALITIES THAT MAY HAVE CONTRIBUTED TO THE CAUSE OF THE COMPLAINT. NOTHING KNOWN TO HAVE CONTRIBUTED TO THE COMPLAINT WAS OBSERVED. THE GUIDEWIRE USED IN THIS MFG LOT IS A LAKE REGION GUIDEWIRE, CATALOG # 06508704, INCOMING RECEIVER # 2006137404, VENDOR LOT# P1-982868. THIS LOT PASSED ALL SPEC AT INCOMING. NOTHING KNOWN TO HAVE CONTRIBUTED TO THE COMPLAINT WAS OBSERVED. REVIEW OF RETURNED SAMPLE: ONLY THE WIRE WAS RETURNED. THE WIRE WAS IN TWO PIECES. IT APPEARS AS IF THE WIRE STRETCHED UNTIL IT BROKE. THE COMPLAINT SAMPLE AND INFO WERE FORWARDED TO THE VENDOR FOR FURTHER EVAL. CONCLUSION: THE COMPLAINT INVESTIGATION HAS BEEN CONFIRMED DURING THE VISUAL INSPECTION OF THE RETURNED SAMPLE. THE VISUAL EXAMINATION OF THE RETURNED SAMPLE SHOWED THE COIL SEGMENT SEPARATED FROM THE SHAFT DUE TO A FRACTURE OF THE CORE SHAFT IMMEDIATELY DISTAL OF THE PROXIMAL COIL TO CORE WIRE JOINT PRESENTING INDICATIONS OF BENDING OVERLOAD WITH SOME TORSIONAL LOADING. THE DISTAL ASPECT OF THE COIL WIRE IS STRETCHED. THE BEND DAMAGE APPEARS TO BE CONSISTENT WITH MULTIPLE FAILED ATTEMPTS TO ADVANCE AND/OR RETRACT THE SPECIMEN AGAINST A CONSTRAINT OR OBSTRUCTION. THE EXACT CAUSE OF THE COMPLAINT IS UNK. A REVIEW OF THE MFG, INSPECTING AND PACKAGING RECORDS INDICATED THE LOT WAS MFG AND RELEASED TO SPEC. BASED ON THE EVAL OF THE RETURNED SAMPLE, IT APPEARS AS IF PROCEDURAL AND CLINICAL FACTORS MAY HAVE IMPACTED THIS REPORTED COMPLAINT. HOWEVER, ANGIODYNAMICS HAS BEEN MADE AWARE OF THIS COMPLAINT AND HAS OPENED UP A CORRECTIVE ACTION TO ADDRESS THIS ISSUE. WE ARE CURRENTLY LOOKING INTO A NEW WIRE. THE FOLLOWING WARNINGS ARE IN THE INSTRUCTIONS FOR USE TO HELP AVOID THIS TYPE OF COMPLAINT: "NEVER USE FORCE TO REMOVE THE .018" GUIDEWIRE. RESISTANCE CAN DAMAGE THE CATHETER. IF RESISTANCE OR BUNCHING OF THE CATHETER IS OBSERVED, STOP GUIDEWIRE WITHDRAW AND ALLOW THE CATHETER TO RETURN TO NORMAL SHAPE. WITHDRAW BOTH THE CATHETER AND GUIDEWIRE TOGETHER APPROX 2CM AND REATTEMPT GUIDEWIRE REMOVAL. REPEAT THIS PROCEDURE UNTIL THE GUIDEWIRE IS EASILY REMOVED. ONCE THE GUIDEWIRE IS OUT. ADVANCE THE CATHETER INTO THE DESIRED POSITION (ZERO MARK)." "DO NOT ADVANCE THE GUIDEWIRE PAST THE AXILLA WITHOUT FLUOROSCOPIC GUIDANCE." "LEAVING THE GUIDEWIRE IN PLACE, WITHDRAW THE NEEDLE." THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    THE WIRE BECAME STUCK AND FLOPPY END SHEARED AWAY FROM CORE OF WIRE. A NEW WIRE WAS USED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MORPHEUS CT PICC PERIPHERALLY INSERTED CENTRAL CATHETER LJS ANGIODYNAMICS, INC. * 922163

    Patients

    Seq Age Sex Outcome Treatment
    1 *