BEUDAMED
    FDA Adverse Event Other Summary report: N

    MORPHEUS CT PICC

    MDR report key: 972831 · Received April 27, 2007

    Report

    Report Number
    1319211-2007-00013
    Event Type
    Other
    Date Received
    April 27, 2007
    Date of Event
    March 16, 2007
    Report Date
    April 26, 2007
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    LOT HSITORY 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. REVIEW OF RETURNED SAMPLE: THE COMPLAINT SAMPLE WAS RETURNED FOR EVAL AND THE FOLLOWING WAS OBSERVED: THE CATHETER AND THE WIRE WERE RETURNED. NO DEFECTS WERE OBSERVED ON THE CATHETER. THE FLOPPY END OF THE GUIDEWIRE IS KINKED AND BENT. THE RETURNED WIRE INTERFACED WITH THE CATHETER WITHOUT DIFFICULTY. CONCLUSION: THE COMPLAINT INVESTIGATION IS UNCONFIRMED. THE VISUAL EXAMINATION OF THE RETURNED SAMPLE SHOWED MULIPLE BENDS IN THE COIL TIP. THIS DAMAGE APPEARS TO BE CONSISTENT WITH MULTIPLE FAILED ATTEMPTS TO ADVANCE AND/OR RETRACT THE SPECIMEN AGAINST A CONSTRAINT OR OBSTRUCTION. THE CATHETER SHOWED NO SIGNS OF DAMAGE. THE RETURNED WIRE WAS INTERFACED WITH THE CATHETER WITHOUT DIFFICULTY. THE REPORTED COMPLAINT COULD BE DUPLICATED. THE EXACT CAUSE OF THE COMPLAINT IS UNK. A REVIEW OF THE MANUFACTURING, INSPECTING AND PACKAGING RECORDS INDICATED THE LOT WAS MANUFACTURED AND RELEASED TO SPECIFICATION. BASED ON THE EVALUATION OF THE RETURNED SAMPLE IT APPEARS AS IF 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 FOLLLOWING 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." THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. NO FURTHER ACTION REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    THE PICC WAS INSERTED OVER THE WIRE AND THE WIRE COULD NOT COME OUT AFTER THE PICC PLACEMENT WAS CORRECT. HAD TO REINSERT PICC WITH A NEW KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MORPHEUS CT PICC PERIPHERALLY INSERTED CENTRAL CATHETER LJS ANGIODYNAMICS, INC. * 922227

    Patients

    Seq Age Sex Outcome Treatment
    1 *