BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KRA CATHETER, CONTINUOUS FLUSH

    MDR report key: 8386124 · Received March 4, 2019

    Report

    Report Number
    1820334-2019-00430
    Event Type
    Injury
    Date Received
    March 4, 2019
    Report Date
    April 10, 2019
    Manufacturer
    COOK INC
    Product Code
    KRA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION - EVALUATION. REVIEWS OF THE DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURER¿S INSTRUCTIONS, 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 THIS EVENT CANNOT BE TRACED TO THE DEVICE BUT IS LIKELY RELATED TO THE PATIENT¿S CONDITION. PER THE INITIAL REPORT, THE PATIENT¿S ANATOMY WAS HEAVILY CALCIFIED, AND THE QUICK CROSS DEVICE USED TO RETRIEVE THE COMPLAINT DEVICE ALSO GOT STUCK DURING THE PROCEDURE. 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

    BRAND NAME AND MODEL #: UNAVAILABLE AS THE DEVICE LOT NUMBER, RPN, AND GPN ARE UNKNOWN. INITIAL REPORTER OCCUPATION: OTHER HEALTHCARE PROFESSIONAL. PMA/510(K) NUMBER = UNAVAILABLE AS THE DEVICE LOT NUMBER, RPN, AND GPN ARE UNKNOWN. (B)(4). 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 PORTION OF AN UNSPECIFIED CXI CATHETER (PRODUCT AND LOT NUMBERS WERE NOT PROVIDED) SEPARATED INSIDE THE (B)(6) YEAR OLD MALE'S HEAVILY CALCIFIED ANATOMY DURING TREATMENT OF TIBIAL LESIONS. EVENT DATE WAS NOT PROVIDED. ACCESS WAS GAINED WITH THE COMPLAINT DEVICE VIA THE PEDAL ACCESS. WHILE REMOVING THE CATHETER, IT SNAPPED LEAVING ABOUT 40 CM IN THE BODY. ANOTHER MANUFACTURER'S QUICK CROSS CATHETER WAS INSERTED OVER THE SAME WIRE THROUGH THE PEDAL ACCESS IN ORDER TO PUSH THE REMAINING PORTION OF THE CATHETER THROUGH THE GROIN. WHEN THEY TRIED TO REMOVE THE QUICK CROSS CATHETER, IT ALSO BECAME STUCK BUT WAS EVENTUALLY REMOVED AND THE PROCEDURE WAS COMPLETED AS PLANNED. A PORTION OF THE COMPLAINT DEVICE DID NOT REMAIN IN THE PATIENT'S ANATOMY. NO ADVERSE EFFECTS AND NO ADDITIONAL PROCEDURES WERE REQUIRED AS A RESULT OF THIS OCCURRENCE. 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
    179761 KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention PREVIOUSLY MENTIONED| PREVIOUSLY MENTIONED