BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUNDERQUIST SUPPORT WIRE GUIDE

    MDR report key: 6600523 · Received May 31, 2017

    Report

    Report Number
    3002808486-2017-01143
    Event Type
    Malfunction
    Date Received
    May 31, 2017
    Date of Event
    May 5, 2017
    Report Date
    May 5, 2017
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DQX
    UDI-DI
    00827002467293
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REF# (B)(4). A1) UNKNOWN AS INFORMATION WAS NOT PROVIDED. A2) UNKNOWN AS INFORMATION WAS NOT PROVIDED. A4) UNKNOWN AS INFORMATION WAS NOT PROVIDED. G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. G5) SIMILAR TO DEVICE UNDER 510(K): K061670. (B)(4). INVESTIGATION IS STILL IN PROGRESS. 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.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: WIRE DISINTEGRATED INTO INDIVIDUAL STRANDS WHEN BEING PULLED OUT OF THE CATHETER. THE PHYSICIAN WASN´T ABLE TO PULL OUT THE GUIDE WIRE THROUGH THE CANNULA OF THE LABS-100-J SET. AFTER HE MANAGED TO PULL THE GUIDE WIRE OUT, THE WIRE WAS PARTLY BROKEN, BUT NOT TOTALLY BROKEN. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016032. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: INVESTIGATION IS BASED ON THE EVENT DESCRIPTION AND THE RETURNED PRODUCT. ONE WIRE GUIDE WAS RETURNED AND INVESTIGATION FOUND THE COILED PORTION SEVERELY ELONGATED. THE SAFETY WIRE HAS FRACTURED APPROX. 32CM FROM THE TIP/WELDING. THERE IS NO EVIDENCE TO SUGGEST THAT THIS WIRE GUIDE WAS NOT MANUFACTURED TO SPECIFICATIONS, BUT IT IS SUGGESTED THAT IT ENCOUNTERED RESISTANCE BEYOND ITS INTENDED DESIGN WHEN "PHYSICIAN WASN'T ABLE TO PULL OUT THE GUIDE WIRE THROUGH THE CANNULA OF THE LABS-100-J SET. AFTER HE MANAGED TO PULL THE GUIDE WIRE OUT THE WIRE WAS PARTLY BROKEN, BUT NOT TOTALLY BROKEN." IFU: WITHDRAWAL OR MANIPULATION OF WIRE GUIDE THROUGH A NEEDLE TIP MAY RESULT IN DAMAGE OR BREAKAGE. NO EVIDENCE TO SUGGEST PRODUCT WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381205 LUNDERQUIST SUPPORT WIRE GUIDE HAP WIRE GUIDE DQX WILLIAM COOK EUROPE G46729 00827002467293

    Patients

    Seq Age Sex Outcome Treatment
    1