BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSCATH SUPPORT CATHETER

    MDR report key: 8395609 · Received March 6, 2019

    Report

    Report Number
    1820334-2019-00548
    Event Type
    Malfunction
    Date Received
    March 6, 2019
    Date of Event
    February 5, 2019
    Report Date
    April 5, 2019
    Manufacturer
    COOK INC
    Product Code
    KRA
    UDI-DI
    00827002515741
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION - EVALUATION A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, DEVICE HISTORY RECORD, DOCUMENTATION, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE USED COMPLAINT DEVICE WAS RETURNED WITH A COMPETITOR'S WIRE LODGED IN IT. ALL MARKER BANDS WERE PRESENT. ELONGATION AND TWISTING WERE NOTED WHICH WERE PREVIOUSLY REPORTED. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS ONE NONCONFORMANCE FOR SHAFT DAMAGE; HOWEVER, THE AFFECTED UNITS WERE SCRAPPED. THERE IS NO EVIDENCE TO SUPPORT NON-CONFORMING PRODUCT IN-HOUSE OR IN THE FIELD.A COMPLAINT HISTORY SEARCH REVEALED THAT THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITE CONCLUSION FOR THE EVENT COULD NOT BE ESTABLISHED. THE PATIENT'S CALCIFIED ANATOMY MAY HAVE BEEN A CONTRIBUTING FACTOR. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS. 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

    OCCUPATION: NON-HEALTHCARE PROFESSIONAL. PMA/510(K) NUMBER: K161801. DEVICE EVALUATION HAS BEGUN; HOWEVER, A CONCLUSION IS NOT YET AVAILABLE. 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, AN (B)(6) MALE WAS UNDERGOING AN AORTOILIIOFEMORAL (AIF) PROCEDURE OF THE CALCIFIED POSTERIOR TIBIAL ARTERY VIA PEDAL ACCESS WHEN ANOTHER MANUFACTURER'S 0.14 GUIDE WIRE BECAME STUCK INSIDE THE CROSSCATH SUPPORT CATHETER. THE CROSSCATH SUPPORT CATHETER WAS REMOVED. DETAILS REPORTEDLY ARE UNAVAILABLE; THEREFORE, IT IS UNKNOWN IF ANOTHER CROSSING CATHETER WAS USED DURING THE PROCEDURE. THE PHYSICIAN WAS UNABLE TO TREAT THE TARGET LESION VIA THE PEDAL ACCESS DESPITE CONTINUED ATTEMPTS TO CROSS IT. THE ACCESS POINT WAS CHANGED TO THE GROIN AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT REPORTEDLY WAS RECOVERING AS EXPECTED AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS OCCURRENCE. UPON RECEIPT OF THE COMPLAINT DEVICE, IT WAS NOTED BY THE COMPLAINT INVESTIGATOR ON (B)(4) 2019 TO HAVE "ELONGATION ON THE DISTAL SECTION OF THE CATHETER. THE ELONGATION WAS APPROXIMATELY 56.6CM IN LENGTH, MEASURING FROM DISTAL TIP. UNDER THE STRAIN RELIEF A SEVERELY TWISTED SECTION WAS NOTED AND MEASURED APPROXIMATELY 2CM IN LENGTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187506 CROSSCATH SUPPORT CATHETER KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC G51574 9254935 00827002515741

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR