BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE

    MDR report key: 6645934 · Received June 16, 2017

    Report

    Report Number
    3002808486-2017-01262
    Event Type
    Injury
    Date Received
    June 16, 2017
    Date of Event
    May 22, 2017
    Report Date
    May 22, 2017
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DQX
    UDI-DI
    00827002454088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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). D4) CATALOG #: TSCMG-35-300-LESDC 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.

    Description of Event or Problem · 0

    A MALE PATIENT UNDERWENT TEVAR. ACCESS WAS GAINED FROM RIGHT COMMON ILIAC ARTERY (CIA), SINCE ACCESS VESSEL WAS TOO THIN. AFTER SECURE THE ACCESS ROUTE, THE WIRE GUIDE WAS EXCHANGED FOLLOWED BY ANGIOGRAPHY. THEN, THE PHYSICIAN ATTEMPTED TO ADVANCE THE DELIVERY SYSTEM OVER THE WIRE GUIDE, HOWEVER, IT COULD NOT BE ADVANCED. THEREFORE, ANOTHER WIRE GUIDE (TSCMG-35-260-E-LESDC/LOT# UNKNOWN) WAS USED INSTEAD, AND IT PASSED THROUGH THE DEVICE SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED WITHOUT PROBLEMS. STATED BY THE PHYSICIAN: "THE WIRE GUIDE WAS NOT EVEN KINKED, HOWEVER IT COULD NOT BE PASSED THROUGH THE DELIVERY SYSTEM. I SUSPECT THAT THE WIRE GUIDE HAS INDIVIDUAL DIFFERENCE OR IT WAS THICK ORIGINALLY". PATIENT OUTCOME: THERE HAVE BEEN NO ADVERSE EFFECT TO THE PATIENT REPORTED.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016032. (B)(4). NAME AND ADDRESS FOR IMPORTER SITE: (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE WIRE GUIDE WAS RETURNED INSIDE THE ORIGINAL HOLDER, BUT PLACED UPSIDE DOWN, IE WITH THE FLEXIBLE TIP OUTSIDE THE PROXIMAL END OF THE HOLDER. EXCEPT FROM MINOR KINKS AT THE DISTAL TIP THE WIRE GUIDE WAS UNIFORM AND WITHOUT ANY DAMAGES AND THE OUTER DIAMETER WAS ACCORDING TO SPECIFICATIONS. BASED ON THESE FINDINGS THE EXACT REASON WHY THE WIRE GUIDE COULD NOT BE ADVANCED THROUGH THE ZENITH DEVICE CANNOT BE DETERMINED. IT IS NOTED THAT THE PROCEDURE WAS COMPLETED WITH A LUNDERQUIST WIRE GUIDE WITH EXTENDED CURVE AND THAT THERE WERE NO ADVERSE EFFECT TO THE PATIENT. NO EVIDENCE TO SUGGEST THAT THIS WIRE GUIDE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT IT DID NOT PERFORM AS INTENDED. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428689 LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE HAP WIRE GUIDE DQX WILLIAM COOK EUROPE G45408 00827002454088

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening