BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KRA CATHETER, CONTINUOUS FLUSH

    MDR report key: 8422458 · Received March 14, 2019

    Report

    Report Number
    1820334-2019-00623
    Event Type
    Injury
    Date Received
    March 14, 2019
    Report Date
    April 30, 2019
    Manufacturer
    COOK INC
    Product Code
    KRA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION - EVALUATION: REVIEWS OF THE DEVICE DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURER¿S INSTRUCTIONS, AND QUALITY CONTROL 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 MANUFACTURER¿S 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 ROOT 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

    BRAND NAME, UDI #: UNAVAILABLE AS THE DEVICE LOT NUMBER, RPN AND GPN ARE UNKNOWN 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 PHYSICIAN STATED THAT A "COUPLE" OF CXIS FRACTURED IN THE PATIENT " A WHILE AGO". LOT AND PRODUCT NUMBERS WERE NOT PROVIDED. THIS INFORMATION WAS ORIGINALLY REPORTED IN MEDWATCH 1820334-2019-00458. SINCE THAT REPORT, ADDITIONAL INFORMATION HAS BEEN PROVIDED INDICATING THERE WERE TWO SEPARATE EVENTS. THIS REPORT WILL DETAIL INFORMATION RECEIVED FOR PATIENT #2. A FOLLOW UP REPORT WILL BE SUBMITTED FOR PATIENT #1 (MEDWATCH 1820334-2019-00458). THE FOLLOWING INFORMATION WAS PROVIDED ON 13MAR2019: PATIENT #2 WAS UNDERGOING A CENTRAL VENOUS OCCLUSION PROCEDURE, SPECIFICALLY AN ILIO-FEMORAL DEEP VEIN THROMBOSIS (DVT) VIA THE COMMON FEMORAL VEIN. THERE WAS NO DIFFICULTY UPON INSERTION. AS THE COMPLAINT CATHETER AND WIRE WERE BEING REMOVED, IT WAS OBSERVED THAT THE COMPLAINT DEVICE HAD FRACTURED, MEANING THE TIP OF THE CATHETER (LAST 7-15 CENTIMETER (CM)) SEPARATED FROM THE REST OF THE CATHETER. AS THE TIP OF THE CATHETER REMAINED IN THE PATIENT, A TWO CM INCISION WAS MADE IN THE THIGH AND THE TIP WAS REMOVED. NOTHING REMAINED IN THE PATIENT, AND THE OVERALL OUTCOME WAS SUCCESSFUL WITH RECANALIZATION OF A NEW CXI CATHETER. SPECIFIC LOT NUMBER CANNOT BE PROVIDED AT THIS POINT. THE COMPLAINT DEVICE WAS DISCARDED BY THE FACILITY AND NOT AVAILABLE TO AID THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215908 KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNSPECIFIED WIRE GUIDE