BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE

    MDR report key: 6313394 · Received February 9, 2017

    Report

    Report Number
    3002808486-2017-00373
    Event Type
    Injury
    Date Received
    February 9, 2017
    Date of Event
    February 5, 2015
    Report Date
    February 5, 2015
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DQX
    UDI-DI
    10827002523453
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG# TSCMG-35-300-LESDC-JP. SIMILAR TO DEVICE UNDER 510(K) K061670. (B)(4). BASED ON THE PROVIDED INFORMATION IT IS PLAUSIBLE THAT THE VESSEL RUPTURE WAS CAUSED BY EXCESSIVE FORCE APPLIED ON THE SYSTEM. NO EVIDENCE TO SUGGEST DEVICE NOT MANUFACTURED TO CURRENT SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. MANUFACTURER REF# (B)(4).

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A PATIENT UNDERWENT EVAR FOR (B)(4) WITH GORE'S DEVICE (EXLUDER). THE COMPLAINT WIRE GUIDE PERFORATED TO THE PATIENTS' VESSEL, THEREFORE THE PROCEDURE WAS CONVERTED TO OPEN SURGERY FOR AORTIC RUPTURE. ADDITIONAL INFORMATION RECEIVED 09FEB2015. ON (B)(6) 2015 A (B)(6) MALE PATIENT UNDERWENT EVAR FROM LEFT, THE PATIENT ANATOMICAL FORM WAS SUITABLE FOR ENDOVASCULAR REPAIR AND THE PROCEDURE WAS PERFORMED AS LABELED. THE PHYSICIAN ADVANCED THE WIRE GUIDE (RADIFOCUS/TERUMO) ASCENDING DIRECTION FOLLOWED BY DELIVERING THE PIGTAIL, THEN REPLACED THE WIRE GUIDE WITH THE COMPLAINT DEVICE AS USUAL. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE PIGTAIL WITHOUT FLUOROSCOPIC CONTROL, HE NOTICED THE COMPLAINT DEVICE CREATED THE LOOP AT THE ABDOMINAL REGION OF THE PATIENT. THEREFORE HE WAS TRYING TO RESOLVE THE LOOP OF COMPLAINT DEVICE BY PULLING IT, HOWEVER THE COMPLAINT DEVICE GOT STACKED BETWEEN CIA AND EIA LESION THAT PUT AN EXTRA LOAD ON THE VESSEL, THEN THE VESSEL RAPTURED. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. ADDITIONAL INFORMATION RECEIVED 18FEB2015. PUNCTURE SITE WAS LEFT, NOT RIGHT AS STATED AT FIRST REPORT. THE COMPLAINT DEVICE GOT STACKED BETWEEN CIA AND EIA. PATIENT OUTCOME:UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97798 LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX WILLIAM COOK EUROPE 10827002523453

    Patients

    Seq Age Sex Outcome Treatment
    1 88 Life Threatening| R