BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CXI SUPPORT CATHETER

    MDR report key: 7095348 · Received December 7, 2017

    Report

    Report Number
    1820334-2017-04354
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    December 4, 2017
    Report Date
    April 2, 2018
    Manufacturer
    COOK INC
    Product Code
    KRA
    UDI-DI
    00827002183728
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: A REVIEW OF THE DIMENSIONAL VERIFICATION, COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, AND A VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE DEVICE WAS RETURNED IN FOUR SEPARATE SECTIONS; THE HUB WAS NOT RETURNED. SECTION 1 (59.2 CM IN LENGTH) HAD 3 CM OF DAMAGE PRESENT ON ONE END. SECTION 2 (11.6 CM IN LENGTH) HAD 2 MM OF ACCORDION DAMAGE. SECTION 3 (4.8 CM IN LENGTH) HAD 8 MM OF ACCORDION DAMAGE. SECTION 4 (13.3 CM IN LENGTH) HAD 4.2 CM OF ACCORDION DAMAGE ON ONE END. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. ALTHOUGH A REVIEW OF SUBASSEMBLY WORK ORDERS FOR DEVICE COMPONENTS REVEALED THREE NONCONFORMANCES WHICH MAY BE RELATED TO THE REPORTED FAILURE MODE, A REVIEW OF THE DEVICE HISTORY RECORD FOR THE FINISHED LOT SHOWED NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WAS ONE OTHER REPORTED COMPLAINT FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IT IS LIKELY, HOWEVER, THAT PATIENT CONDITION WAS RELATED TO THE EVENT. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBER = K122796. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE CXI SUPPORT CATHETER HUB BROKE OFF DURING REMOVAL OF THE DEVICE AND CATHETER TUBING SEPARATED. THE PHYSICIAN UNSUCCESSFULLY ATTEMPTED TO CROSS THE PATIENT'S CHRONIC TOTAL OCCLUSION (CTO) FROM AN UP AND OVER APPROACH, THEN PROCEEDED TO GAIN ACCESS FROM THE DORSALIS PEDIS USING A PEDAL MICROPUNCTURE AND TRIED TO CROSS THE CTO RETROGRADE. A 25 GAUGE APPROACH CTO MICROGUIDE WIRE WITHOUT THE PEDAL SHEATH, USING THE CXI SUPPORT CATHETER OVER THE MIRCROGUIDE WIRE, WAS USED TO SUCCESSFULLY CROSS THE CTO WITH NOTED DIFFICULTLY. THE MICROGUIDE WIRE WAS ADVANCED THROUGH THE CTO, AND AS THE PHYSICIAN ATTEMPTED TO REMOVE THE CXI SUPPORT CATHETER IT FELT STUCK TO THE MICROGUIDE WIRE, PROMPTING HIM TO FORCIBLY PULL ON THE CATHETER HUB. THE CATHETER HUB COMPLETELY BROKE OFF OF THE CATHETER, AND THE PHYSICIAN ATTEMPTED REMOVAL OF THE CATHETER WITHOUT THE HUB BY PULLING ON IT FOR 20- 30 MINUTES. THE CATHETER WAS ABLE TO BE COMPLETELY REMOVED; HOWEVER IT BROKE INTO PIECES DURING REMOVAL OVER THE MICROGUIDE WIRE AS THE PHYSICIAN HAD TO USE FORCE IN ORDER TO MAINTAIN WIRE ACCESS. THE MICROGUIDE WIRE WAS SNARED FROM THE UP AND OVER APPROACH, AS INITIALLY INTENDED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ACCORDING TO THE INITIAL REPORTER, THE NO DEVICE PORTION REMAINED IN THE PATIENT, AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877759 CXI SUPPORT CATHETER KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC 00827002183728

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention