BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CXI SUPPORT CATHETER

    MDR report key: 9717014 · Received February 17, 2020

    Report

    Report Number
    1820334-2020-00369
    Event Type
    Injury
    Date Received
    February 17, 2020
    Date of Event
    February 5, 2020
    Report Date
    May 11, 2020
    Manufacturer
    COOK INC
    Product Code
    KRA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARY OF EVENT: AS REPORTED, DURING AN UNSPECIFIED PROCEDURE INVOLVING TREATMENT OF CRITICAL LIMB ISCHEMIA, A CXI SUPPORT CATHETER SEPARATED. ACCESS WAS OBTAINED IN THE LEFT COMMON FEMORAL ARTERY AND A CONTRALATERAL APPROACH WAS USED TO ACCESS THE RIGHT ANTERIOR TIBIAL ARTERY USING ANOTHER MANUFACTURER'S 0.018 INCH WIRE GUIDE. THE COMPLAINT DEVICE WAS ADVANCED THROUGH AN UNSPECIFIED 4 FRENCH SHUTTLE SHEATH. AS THE USER ATTEMPTED TO CROSS THE CHRONIC TOTAL OCCLUSION, THE DEVICE WAS RETRACTED AND RESISTANCE WAS ENCOUNTERED, AT WHICH POINT THE DEVICE "SNAPPED" APPROXIMATELY TWENTY CENTIMETERS FROM THE HUB, INSIDE THE SHEATH AND WITHIN THE PATIENT. THE AORTIC BIFURCATION WAS REPORTEDLY TORTUOUS AND THE VASCULATURE WAS CALCIFIED THROUGHOUT. THE DEVICE WAS FLUSHED WITH SALINE AND ROTAGLIDE PRIOR TO THE PROCEDURE. THE DEVICE WAS NOT USED WITH A POWER INJECTOR. BECAUSE THE CATHETER SEPARATED WITHIN THE SHEATH, WHICH WAS OVER THE BIFURCATION, INITIAL ATTEMPTS TO SNARE THE DEVICE FROM THE ORIGINAL ACCESS POINT WERE UNSUCCESSFUL DUE TO ISSUES WITH VISUALIZATION AND MANEUVERABILITY. A SECOND CXI CATHETER WAS INSERTED VIA PEDAL ACCESS AND WAS ADVANCED OVER THE EXISTING WIRE GUIDE. THE SECOND CXI WAS THEN USED TO PUSH THE SEPARATED PORTION OF THE COMPLAINT DEVICE OVER THE WIRE AND OUT OF THE ORIGINAL FEMORAL ACCESS SITE. ATTEMPTS TO REMOVE THE SEPARATED PORTION OF THE DEVICE REPORTEDLY EXTENDED THE PROCEDURE BY TWO TO THREE HOURS. THE ORIGINAL PROCEDURE WILL BE RESCHEDULED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AS WELL AS A VISUAL INSPECTION OF THE COMPLAINT DEVICE WAS CONDUCTED DURING THE INVESTIGATION. INSPECTION OF THE COMPLAINT DEVICE CONFIRMED THE PRESENCE OF BIOMATTER. THE PROXIMAL SECTION OF THE DEVICE MEASURED 30CM FROM THE VALVE WITH 2CM OF THE OUTER LINING EXITING THE TIP. THE CATHETER SHAFT WAS TWISTED AND WRINKLED UNDER THE VALVE. THE DISTAL SECTION MEASURED 121.1CM AND WAS CURVED WITH SLIGHT BENDS NOTED. THE ENDHOLE WAS OUT OF ROUND. THE CATHETER WAS FRAYED AT THE SEPARATION POINT. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS ATTEMPTED; HOWEVER, THE LOT NUMBER IS UNKNOWN AND THEREFORE IT IS UNKNOWN IF ANY NON-CONFORMANCES OR ADDITIONAL COMPLAINTS ARE RELATED TO THE SAME LOT. A DEVICE MASTER RECORD REVIEW WAS PERFORMED, INCLUDING DEVICE SPECIFICATIONS, DRAWINGS, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE INFORMATION PROVIDED UPON REVIEW OF COMPLAINT FILE PROVIDES EVIDENCE TO SUPPORT THAT THE DEVICE AND ITEMS IN THE LOT WERE MANUFACTURED TO SPECIFICATION. THE IFU STATES: ¿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." THE MANUFACTURING INSTRUCTIONS AND QUALITY CONTROL PROCEDURES WERE REVIEWED, AND NO GAPS WERE DISCOVERED. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT CAUSE OF THIS EVENT CAN BE TRACED TO THE PATIENT¿S ANATOMY, AS THE TWISTING DAMAGE UNDERNEATH THE STRAIN RELIEF SUGGESTS AN INABILITY TO TRANSFER TORQUE TO THE TIP OF THE DEVICE. THE TORTUOSITY AND CALCIFICATION WITHIN THE PATIENT¿S ANATOMY RESTRICTED MOVEMENT, PLACING THE TORQUE FORCES ON THE SHAFT INSTEAD OF THE TIP, LEADING TO SEPARATION. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED AT THIS TIME. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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 = K122796. (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

    AS REPORTED, DURING AN UNSPECIFIED PROCEDURE INVOLVING TREATMENT OF CRITICAL LIMB ISCHEMIA, A CXI SUPPORT CATHETER SEPARATED. ACCESS WAS OBTAINED IN THE LEFT COMMON FEMORAL ARTERY AND A CONTRALATERAL APPROACH WAS USED TO ACCESS THE RIGHT ANTERIOR TIBIAL ARTERY USING ANOTHER MANUFACTURER'S 0.018 INCH WIRE GUIDE. THE COMPLAINT DEVICE WAS ADVANCED THROUGH AN UNSPECIFIED 4 FRENCH SHUTTLE SHEATH. AS THE USER ATTEMPTED TO CROSS THE CHRONIC TOTAL OCCLUSION, THE DEVICE WAS RETRACTED AND RESISTANCE WAS ENCOUNTERED, AT WHICH POINT THE DEVICE "SNAPPED" APPROXIMATELY TWENTY CENTIMETERS FROM THE HUB, INSIDE THE SHEATH AND WITHIN THE PATIENT. THE AORTIC BIFURCATION WAS REPORTEDLY TORTUOUS AND THE VASCULATURE WAS CALCIFIED THROUGHOUT. THE DEVICE WAS FLUSHED WITH SALINE AND ROTAGLIDE PRIOR TO THE PROCEDURE. THE DEVICE WAS NOT USED WITH A POWER INJECTOR. BECAUSE THE CATHETER SEPARATED WITHIN THE SHEATH, WHICH WAS OVER THE BIFURCATION, INITIAL ATTEMPTS TO SNARE THE DEVICE FROM THE ORIGINAL ACCESS POINT WERE UNSUCCESSFUL DUE TO ISSUES WITH VISUALIZATION AND MANEUVERABILITY. A SECOND CXI CATHETER WAS INSERTED VIA PEDAL ACCESS AND WAS ADVANCED OVER THE EXISTING WIRE GUIDE. THE SECOND CXI WAS THEN USED TO PUSH THE SEPARATED PORTION OF THE COMPLAINT DEVICE OVER THE WIRE AND OUT OF THE ORIGINAL FEMORAL ACCESS SITE. ATTEMPTS TO REMOVE THE SEPARATED PORTION OF THE DEVICE REPORTEDLY EXTENDED THE PROCEDURE BY TWO TO THREE HOURS. THE ORIGINAL PROCEDURE WILL BE RESCHEDULED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179815 CXI SUPPORT CATHETER KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention V18 WIRE GUIDE