BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANTATA DUO 2.8 SUPERSELECTIVE MICROCATHETER

    MDR report key: 7865119 · Received September 11, 2018

    Report

    Report Number
    1820334-2018-02602
    Event Type
    Malfunction
    Date Received
    September 11, 2018
    Date of Event
    August 13, 2018
    Report Date
    September 11, 2018
    Manufacturer
    COOK INC
    Product Code
    KRA
    UDI-DI
    10827002238050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: TERUMO 5 FR. SIM1 HYDROPHILIC CATHETER, SYNCHRO 14 GUIDE WIRE. PMA/510(K)#: K101450. (B)(4). INVESTIGATION EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, AND SPECIFICATIONS 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 THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. FROM THE REVIEW OF THE DEVICE MASTER RECORD, THE ROOT CAUSE IS INCONCLUSIVE. NO ADDITIONAL EVALUATION OF THE DEVICE WAS ABLE TO BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED, AND IMAGES WERE NOT PROVIDED. WITHOUT VISUAL, DIMENSIONAL, AND/OR FUNCTIONAL TESTING OF THE PRODUCT, WE ARE UNABLE TO DETERMINE IF THIS COMPLAINT WAS DRIVEN BY A PROCEDURAL OR DEVICE RELATED CAUSE. NEVERTHELESS, THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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 DUO 2.8 SUPERSELECTIVE MICROCATHETER WAS PLACED FOR A UTERINE FIBROID EMBOLIZATION IN A PATIENT WITH A TORTUOUS ANATOMY. DURING THE PROCEDURE, THE PHYSICIAN REMOVED THE CATHETER FOR ASSESSMENT. WHILE FLUSHING WITH SALINE AND CONTRAST SOLUTION WITH A 1 ML SYRINGE, IT WAS OBSERVED THAT A HOLE HAD FORMED IN THE PROXIMAL THIRD OF THE CATHETER. THE PROCEDURE CONTINUED WITH ANOTHER LIKE CATHETER WHICH ADDED TO THE PROCEDURE TIME, BUT DID NOT RESULT IN ANY ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704809 CANTATA DUO 2.8 SUPERSELECTIVE MICROCATHETER KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC N/A 8441811 10827002238050

    Patients

    Seq Age Sex Outcome Treatment
    1