BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WIZDOM SGW

    MDR report key: 612351 · Received June 7, 2005

    Report

    Report Number
    1016427-2005-00161
    Event Type
    Injury
    Date Received
    June 7, 2005
    Date of Event
    March 12, 2005
    Report Date
    June 7, 2005
    Manufacturer
    CORDIS CORPORATION (MIAMI)
    Product Code
    DQX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE THE PT WAS NOTED TO HAVE A HEMODYNAMICALLY NON SIGNIFICANT LOCALIZED SMALL WIRE PERFORATION OF THE RV MARGINAL BRANCH. TWO DAYS LATER A "RE-LOOK" CATH WAS DONE. THERE WAS NO STENOSIS PRESENT AND THE PERFORATION, NOTICED TWO DAYS PRIOR, WAS NO LONGER PRESENT. THIS PT PRESENTED TO THE CATH LAB WITH UNSTABLE ANGINA, 60% LV EJECTION FRACTION AND 2-VESSEL DISEASE IN THE CIRCUMFLEX AND RIGHT CORONARY ARTERY (RCA). PRE-PROCEDURE MEDICATIONS INCLUDED ASA AND STATINS. INTRA-PROCEDURE MEDICATIONS INCLUDED GP IIB/IIIA INHIBITORS, UNFRACTIONED HEPARIN, INTEGRILLIN AND PLAVIX (300MG). PCI WAS PERFORMED ON A 90% DE NOVO, CALCIFIED LESION IN THE 2ND OBTUSE MARGINAL OF A BIFURCATED 2.5MM DIAMETER VESSEL. THE LESION WAS PRE-DILATED BEFORE DEPLOYING A 2.5 X 12MM TAXUS STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WIZDOM SGW CARDIOLOGY WIRES & METALS DQX CORDIS CORPORATION (MIAMI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R