BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPROACH CTO MICROWIRE WIRE GUIDE

    MDR report key: 18038548 · Received October 31, 2023

    Report

    Report Number
    1820334-2023-01482
    Event Type
    Injury
    Date Received
    October 31, 2023
    Date of Event
    October 7, 2023
    Report Date
    August 6, 2024
    Manufacturer
    COOK INC
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2: COMMON NAME & PRODUCT CODE = DQX - WIRE, GUIDE, CATHETER; PDU - CATHETER FOR CROSSING TOTAL OCCLUSIONS. G4: PMA/510(K) NUMBER = K171897. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. **UDI RELATED DATA QUALITY UPDATES ONLY** CORRECTION: D4. 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.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. SUMMARY OF EVENT: AS REPORTED, DURING A LOWER EXTREMITY ANGIOGRAM, THE TIP OF AN APPROACH CTO MICROWIRE WIRE GUIDE SEPARATED AND REMAINS IN THE PATIENT. ACCESS WAS OBTAINED IN THE LEFT COMMON FEMORAL AND RIGHT DORSALIS PEDIS ARTERIES. THE PATIENT HAD A HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY, AN OCCLUDED POPLITEAL ARTERY, AND A PATENT TIBIALIS. THE USER REPORTEDLY ALTERED THE WIRE PRIOR TO USE BY SHAPING AN ANGLE ON IT. AS THE WIRE WAS ADVANCED INTO THE PROXIMAL ANTERIOR TIBIALIS AND DISTAL POPLITEAL ARTERIES, FROM THE DORSALIS PEDIS ACCESS SITE, THE TIP OF THE WIRE SEPARATED PROXIMAL TO THE ANTERIOR TIBIALIS TAKEOFF. THE WIRE WAS NOT MANIPULATED BACKWARDS THROUGH A NEEDLE OR OTHER METAL CANNULA DURING THE PROCEDURE. THE USER ATTEMPTED TO SNARE THE WIRE FRAGMENT; HOWEVER, THIS WAS UNSUCCESSFUL, AND THE TIP OF THE WIRE REMAINS IN THE PATIENT. NO ADDITIONAL PROCEDURES WERE REQUIRED, AND THE PATIENT WAS UNHARMED. THE DOCTOR WILL REPORTEDLY ATTEMPT TO REMOVE THE WIRE FRAGMENT DURING A BYPASS PROCEDURE. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A SEARCH OF SALES AND SHIPMENTS TO THE CUSTOMER FOUND THREE POSSIBLE LOTS FOR THE COMPLAINT DEVICE (14060824, 14365193, AND 14840390). A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO RELEVANT NON-CONFORMANCES ON ANY OF THE POSSIBLE LOTS. A REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL COMPLAINTS FOR ANY OF THE POSSIBLE LOTS. THE PRODUCT IFU STATES ¿ALTERING THE TIP¿S CONFIGURATION OR CURVE MANUALLY MAY DAMAGE THE WIRE GUIDE.¿ A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHR, AND IFU SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NON-CONFORMING DEVICES IN-HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT THE PATIENT¿S ANATOMY AND UNINTENDED USER ERROR CONTRIBUTED TO THIS EVENT. THE ANATOMY WAS REPORTEDLY CALCIFIED AND OCCLUDED, AND THE USER ALTERED THE WIRE PRIOR TO USE BY SHAPING AN ANGLE. THE IFU WARNS ¿ALTERING THE TIP¿S CONFIGURATION OR CURVE MANUALLY MAY DAMAGE THE WIRE GUIDE.¿ THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND NO ADDITIONAL ESCALATION WAS REQUIRED. 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

    AS REPORTED, DURING A LOWER EXTREMITY ANGIOGRAM, THE TIP OF AN APPROACH CTO MICROWIRE WIRE GUIDE SEPARATED AND REMAINS IN THE PATIENT. ACCESS WAS OBTAINED IN THE LEFT COMMON FEMORAL AND RIGHT DORSALIS PEDIS ARTERIES. THE PATIENT HAD A HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY, AN OCCLUDED POPLITEAL ARTERY, AND A PATENT TIBIALIS. THE USER REPORTEDLY ALTERED THE WIRE PRIOR TO USE BY SHAPING AN ANGLE ON IT. AS THE WIRE WAS ADVANCED INTO THE PROXIMAL ANTERIOR TIBIALIS AND DISTAL POPLITEAL ARTERIES, FROM THE DORSALIS PEDIS ACCESS SITE, THE TIP OF THE WIRE SEPARATED PROXIMAL TO THE ANTERIOR TIBIALIS TAKEOFF. THE WIRE WAS NOT MANIPULATED BACKWARDS THROUGH A NEEDLE OR OTHER METAL CANNULA DURING THE PROCEDURE. THE USER ATTEMPTED TO SNARE THE WIRE FRAGMENT; HOWEVER, THIS WAS UNSUCCESSFUL, AND THE TIP OF THE WIRE REMAINS IN THE PATIENT. NO ADDITIONAL PROCEDURES WERE REQUIRED, AND THE PATIENT WAS UNHARMED. THE DOCTOR WILL REPORTEDLY ATTEMPT TO REMOVE THE WIRE FRAGMENT DURING A BYPASS PROCEDURE.

    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.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2124896 APPROACH CTO MICROWIRE WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK INC G50791 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other PEDAL KIT, 0.014 CXI