BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROSSCATH SUPPORT CATHETER

    MDR report key: 8370073 · Received February 26, 2019

    Report

    Report Number
    1820334-2019-00418
    Event Type
    Injury
    Date Received
    February 26, 2019
    Date of Event
    January 19, 2019
    Report Date
    April 9, 2019
    Manufacturer
    COOK INC
    Product Code
    KRA
    UDI-DI
    00827002515826
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, 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 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. FURTHERMORE, REVIEWS OF THE MANUFACTURES INSTRUCTIONS, DRAWINGS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, NO GAPS WERE DISCOVERED. BASED ON THE INFORMATION PROVIDED AND NO PRODUCT RETURNED, INVESTIGATION HAS CONCLUDED THAT THE CAUSE OF THIS EVENT CANNOT BE TRACED TO THE DEVICE, BUT CAN BE TRACED TO THE PATIENT¿S ANATOMY, AS THE DEVICE WAS USED TO TREAT A HIGHLY CALCIFIED LESION. 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 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.

    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

    PMA/510(K) NUMBER = K161801. (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, DURING A PERIPHERAL INTERVENTION PROCEDURE OF A FEMALE PATIENT'S HIGHLY CALCIFIED LESION, THE CROSSCATH SUPPORT CATHETER BROKE IN HALF UPON REMOVAL FROM THE PATIENT. THE COMPLAINT DEVICE BECAME "STUCK," SUBSEQUENTLY BREAKING OFF IN THE SUPERFICIAL FEMORAL ARTERY. THE BROKEN PORTION WAS SUCCESSFULLY REMOVED USING A SNARE DEVICE THE FOLLOWING DAY. THERE WERE NO PATIENT ADVERSE EFFECTS. THE PATIENT WAS REPORTED BEING "OK". 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
    165875 CROSSCATH SUPPORT CATHETER KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC G51582 8241735 00827002515826

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention