BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANTATA 2.8 SUPERSELECTIVE MICROCATHETER

    MDR report key: 7853083 · Received September 6, 2018

    Report

    Report Number
    1820334-2018-02471
    Event Type
    Malfunction
    Date Received
    September 6, 2018
    Date of Event
    August 8, 2018
    Report Date
    November 27, 2018
    Manufacturer
    COOK INC
    Product Code
    KRA
    UDI-DI
    10827002545356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. INVESTIGATION - EVALUATION. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS AND QUALITY CONTROL OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THAT THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE INSTRUCTIONS FOR USE (IFU) NOTES A PRECAUTION THAT STATES WHEN USING A MICROCATHETER FOR INFUSION OF EMBOLIC AGENTS, THROMBOLYTIC THERAPIES, OR OTHER AGENTS, REFER TO THE APPROPRIATE MANUFACTURER¿S SUGGESTED INSTRUCTIONS FOR USE FOR THE PROPER GUIDELINES. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO RELEVANT NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. IT SHOULD BE NOTED THAT THERE WERE NO OTHER COMPLAINTS REPORTED IN THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE CAUSE COULD NOT BE ESTABLISHED, HOWEVER IT IS POSSIBLE THAT A CHEMICAL INCOMPATIBILITY WAS RESPONSIBLE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON 11SEP2018 PROVIDED AN UPDATED PROBLEM DESCRIPTION. THE PHYSICIAN REPORTED THE HUB AND SYRINGE WERE STUCK TOGETHER LIKE GLUE. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: MERIT 1ML MEDALLION SYRINGE MSS011-R AND COOK 1-WAY STOPCOCK POWS-FLL-MLL (ATTACHED TO NEEDLE THAT WAS IN THE CHEMO VIAL) OCCUPATION: UNKNOWN PMA/510(K) #: K101450. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED A CANTATA 2.8 SUPERSELECTIVE MICROCATHETER WAS USED FOR CHEMO EMBOLIZATION TARGETING A HEPATIC TUMOR. THE CANTATA CATHETER WAS IN PLACE FOR A TOTAL TIME OF AROUND 1 HOUR. THE CANTATA WAS INITIALLY FLUSHED WITH HEPARINIZED SOLUTION BEFORE THE CHEMO MIX WAS DELIVERED. THE CHEMO MIX CONSISTED OF 20MG MITOMYCIN, 30MG OF DOXORUBICIN, IOTHALAMATE MEGLUMINE, 10ML OF LIPIODOL, AND 60% 10ML CONTRAST (EITHER 320 OR 350 MG/ML VISIPAQUE). IN GIVING THE CHEMO AGENT, THE PHYSICIAN ALTERNATED 1CC LIDOCAINE AND 3CC OF CHEMO MIX. FOUR CHEMO EMBOLIZATION DOSES WERE ABLE TO BE DELIVERED THROUGH THE CATHETER. AFTER THE FIRST FOUR DOSES WERE DELIVERED THE SYRINGE WAS UNABLE TO BE REMOVED FROM THE CATHETER DUE TO THE CATHETER HUB "MELTING" TO THE SYRINGE. HE ALSO CONFIRMED THAT HE DID NOT USE A STOPCOCK DURING THE CASE AND DID USE A CARBON FIBER SYRINGE. PICTURES OF THE DEVICE WERE REQUESTED BUT ARE NOT AVAILABLE. THE REPORTER STATED THE CATHETER AND SYRINGE WERE NOT SAVED SINCE THEY CONTAINED THE CHEMO EMBOLIZATION AGENT. THE CATHETER WAS CUT AND A BOSTON SCIENTIFIC DIREXION CATHETER WAS PLACED USING A 300CM EXCHANGE WIRE. THIS MICROCATHETER ADMINISTERED THE THREE REMAINING DOSES. THE TOTAL DOSING TIME FOR THE PATIENT WAS AROUND 10-20 MIN. NO ADDITIONAL PROCEDURES WERE REQUIRED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690632 CANTATA 2.8 SUPERSELECTIVE MICROCATHETER KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC N/A 8894847 10827002545356

    Patients

    Seq Age Sex Outcome Treatment
    1