BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUGE GUIDE WIRE

    MDR report key: 1860742 · Received October 7, 2010

    Report

    Report Number
    2134265-2010-04567
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 11, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    DQX
    PMA / PMN Number
    K973945
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE TIP OF THE GUIDE WIRE DETACHED. TWO DAYS PRIOR TO THIS PROCEDURE, THE PATIENT PRESENTED WITH A MYOCARDIAL INFARCTION. THE RIGHT CORONARY ARTERY (RCA) WAS FOUND TO BE TOTALLY OCCLUDED AND A SUCCESSFUL INTERVENTION WAS PERFORMED. DURING THAT PROCEDURE, VESSEL CLOSURE WAS ALSO NOTED IN THE CIRCUMFLEX (CX) AND THE HIGH OBTUSE MARGINAL (OM)/RAMUS, THEREFORE THE PATIENT WAS SCHEDULED TO RETURN FOR ANOTHER TREATMENT PROCEDURE. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY. THE TWO DE NOVO TARGET LESIONS WERE LOCATED IN A MODERATELY CALCIFIED AND MODERATELY TORTUOUS BIFURCATION OF THE 95% STENOSED HIGH OBTUSE MARGINAL/RAMUS AND THE 90% STENOSED CIRCUMFLEX (CX). THE LESIONS WERE CONCENTRICALLY SHAPED. THE VESSEL DIAMETER OF THE HIGH OM/RAMUS WAS 2.5-2.75MM AND THE CX WAS 2.25MM AND WAS DIFFUSELY DISEASED. TWO 182CM LUGE GUIDE WIRES WERE PLACED IN THE LESIONS. PRE-DILATATION OF THE HIGH OM/RAMUS WAS PERFORMED WITH A 2.25X20 APEX BALLOON CATHETER FOLLOWED BY IMPLANTATION OF A 2.25X18 NON BSC DRUG-ELUTING STENT IN THE PROXIMAL OM/RAMUS. A 2.25X15 APEX BALLOON CATHETER WAS USED TO PERFORM PRE-DILATATION OF THE CX FOLLOWED BY THE IMPLANTATION OF A 2.25X8 NON BSC DRUG-ELUTING STENT. THE STENTS WERE DEPLOYED AT NOMINAL PRESSURE. POST-DILATATION WAS PERFORMED UTILIZING THE AFOREMENTIONED BALLOONS IN THEIR RESPECTIVE STENTS. UPON REMOVAL OF THE LUGE GUIDE WIRES, IT WAS NOTED THAT A 30MM FRAGMENT OF ONE OF THE LUGE GUIDE WIRES WAS IN THE DISTAL EDGE OF THE 2.25X18 NON BSC STENT; IT HAD DETACHED FROM THE LUGE GUIDE WIRE USED IN THE HIGH OM/RAMUS. A NON BSC SNARING KIT WAS UTILIZED IN AN UNSUCCESSFUL ATTEMPT TO REMOVE THE WIRE FRAGMENT. THE PATIENT WAS SENT TO THE OR WHERE THE WIRE TIP WAS REMOVED SUCCESSFULLY DURING AN EMERGENT CABG. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS OK. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUGE GUIDE WIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MIAMI H7491213001J2 13629591

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R 2.25X20 AND 2.25X15 APEX BALLOON CATHETERS| 2.25X18 AND 2.25X8 CYPHER DRUG-ELUTING STENTS| 182CM LUGE GUIDE WIRE