BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPROACH CTO MICROWIRE WIRE GUIDE

    MDR report key: 17950938 · Received October 17, 2023

    Report

    Report Number
    1820334-2023-01393
    Event Type
    Malfunction
    Date Received
    October 17, 2023
    Date of Event
    September 21, 2023
    Report Date
    August 7, 2024
    Manufacturer
    COOK INC
    Product Code
    DQX
    UDI-DI
    00827002507937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. D2: COMMON NAME & PRODUCT CODE = DQX WIRE, GUIDE, CATHETER & PDU CATHETER FOR CROSSING TOTAL OCCLUSIONS E3: OCCUPATION = LAB MANAGER. G4: PMA/510(K) # = K171897. H3: DEVICE EVALUATED BY MFG = OTHER (81) - 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. 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

    **UDI RELATED DATA QUALITY UPDATES ONLY** 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 PROCEDURE INVOLVING INTERVENTION OF THE SUPERFICIAL FEMORAL ARTERY, THE TIP OF AN APPROACH CTO MICROWIRE WIRE GUIDE UNRAVELED. ACCESS WAS OBTAINED THROUGH THE POSTERIOR TIBIAL ARTERY TO TREAT THE CHRONIC TOTALLY OCCLUDED (CTO) SUPERFICIAL FEMORAL ARTERY. THE PATIENT'S ANATOMY WAS CALCIFIED. THE WIRE WAS FULLY ADVANCED THROUGH A COOK CXI CATHETER AND UPON MOVING THE WIRE "IN AND OUT OF THE CATHETER" THE TIP SEPARATED BUT DID NOT DETACH. THE WIRE WAS REMOVED AND REPLACED WITH ANOTHER WIRE GUIDE. PER THE REPORTER, RESISTANCE WAS NOT FELT UPON INSERTION OF THE WIRE; HOWEVER, RESISTANCE WAS FELT WHILE ADVANCING THROUGH THE CTO. THE WIRE WAS NOT ALTERED PRIOR TO USE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL PROCEDURES, AND SPECIFICATIONS WERE CONDUCTED DURING THE INVESTIGATION. A VISUAL INSPECTION OF THE COMPLAINT DEVICE WAS ALSO CONDUCTED. THE COMPLAINT DEVICE WAS RETURNED TO COOK FOR INVESTIGATION. PHYSICAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE DISTAL WIRE GUIDE WAS UNRAVELED JUST BELOW THE TIP AND SOME OF THE MANDRIL WAS SHOWING. THE INSTRUCTIONS FOR USE (IFU) STATES ¿THIS PRODUCT IS A DELICATE INSTRUMENT. AVOID FORCEFUL ANGULATION. ALTERING THE TIP¿S CONFIGURATION OR CURVE MANUALLY MAY DAMAGE THE WIRE GUIDE. EXCESSIVE TIGHTENING OF A TORQUE DEVICE MAY ABRADE THE COATING ON THE WIRE GUIDE.¿ A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO RELEVANT NON-CONFORMANCES ON THE LOT. A REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL COMPLAINTS FOR THIS LOT NUMBER. 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, IFU, AND INVESTIGATION OF THE RETURNED DEVICE 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 CONTRIBUTED TO THIS EVENT, AS THE WIRE TIP UNRAVELED WHILE TRYING TO PASS THROUGH CALCIFIED ANATOMY. 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 PROCEDURE INVOLVING INTERVENTION OF THE SUPERFICIAL FEMORAL ARTERY, THE TIP OF AN APPROACH CTO MICROWIRE WIRE GUIDE UNRAVELED. ACCESS WAS OBTAINED THROUGH THE POSTERIOR TIBIAL ARTERY TO TREAT THE CHRONIC TOTALLY OCCLUDED (CTO) SUPERFICIAL FEMORAL ARTERY. THE PATIENT'S ANATOMY WAS CALCIFIED. THE WIRE WAS FULLY ADVANCED THROUGH A COOK CXI CATHETER AND UPON MOVING THE WIRE "IN AND OUT OF THE CATHETER" THE TIP SEPARATED BUT DID NOT DETACH. THE WIRE WAS REMOVED AND REPLACED WITH ANOTHER WIRE GUIDE. PER THE REPORTER, RESISTANCE WAS NOT FELT UPON INSERTION OF THE WIRE; HOWEVER, RESISTANCE WAS FELT WHILE ADVANCING THROUGH THE CTO. THE WIRE WAS NOT ALTERED PRIOR TO USE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    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
    2078500 APPROACH CTO MICROWIRE WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK INC G50793 15489108 00827002507937

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female .035 CXI CATHETER| 5/6 SLENDOR SHEATH