BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CXI SUPPORT CATHETER

    MDR report key: 8528746 · Received April 18, 2019

    Report

    Report Number
    1820334-2019-00809
    Event Type
    Malfunction
    Date Received
    April 18, 2019
    Date of Event
    April 2, 2019
    Report Date
    April 29, 2019
    Manufacturer
    COOK INC
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION/EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DOCUMENTATION, DRAWING, MANUFACTURER¿S INSTRUCTION, QUALITY CONTROL, AND SPECIFICATIONS WERE 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. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THE DEVICE IS SHIPPED WITH INSTRUCTION FOR USE (IFU) WHICH NOTES: ¿THE CATHETER SHOULD NOT BE ADVANCED THROUGH AN AREA OF RESISTANCE UNLESS THE SOURCE OF RESISTANCE IS IDENTIFIED BY FLUOROSCOPY AND APPROPRIATE STEPS ARE TAKEN TO REDUCE OR REMOVE THE OBSTRUCTION." FURTHERMORE, REVIEWS OF THE MANUFACTURES INSTRUCTIONS, DRAWINGS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. BASED ON THE INFORMATION PROVIDED AND NO PRODUCT RETURNED, INVESTIGATION HAS CONCLUDED THAT A CAUSE FOR THIS EVENT COULD NOT BE ESTABLISHED. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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 ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    (B)(6). PMA/510(K) NUMBER = K122796. 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 CXI SUPPORT CATHETER BROKE INSIDE A PATIENT. PATIENT DEMOGRAPHICS AND ADDITIONAL EVENT DETAILS HAVE NOT BEEN PROVIDED. NO ADVERSE EFFECTS HAVE BEEN REPORTED. ADDITIONAL INFORMATION REGARDING EVENT AND PATIENT DETAILS INCLUDING PATIENT OUTCOME HAVE BEEN REQUESTED BUT NOT YET RECEIVED. PER THE COMPLAINANT, THE COMPLAINT DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER TO AID IN THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321578 CXI SUPPORT CATHETER KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1