BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUPPLY : 451006-4; CABL

    MDR report key: 1932851 · Received December 20, 2010

    Report

    Report Number
    2939204-2010-01156
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K001083
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY. THE COIL DETACHED OUTSIDE THE MICROCATHETER AND NOT INSIDE THE PATIENT AS PREVIOUSLY REPORTED. THE COIL HAD NOT BEEN SOAKED IN SALINE PRIOR TO USE AND CONTINUOUS FLUSH WAS NOT MAINTAINED. THE PHYSICIAN CONFIRMED THAT BOTH THE TWIST LOCK ON THE INTRODUCER SHEATH AND THE ROTATING HEMOSTASIS VALVE WERE OPENED TO ALLOW THE COIL TO BE ADVANCED. NO FRICTION WAS ENCOUNTERED PRIOR TO THE COIL DETACHING. BOSTON SCIENTIFIC HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS THE REQUIREMENTS OF A REPORTABLE EVENT FOR THE DEVICE IN QUESTION.

    Description of Event or Problem · 1

    THE COIL PREMATURELY DETACHED DURING DEPLOYMENT, THE PHYSICIAN WAS ABLE TO IMPLANT THE COIL INTO THE ANEURYSM. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    THE COIL DETACHED OUTSIDE THE MICROCATHETER. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUPPLY : 451006-4; CABL DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK M00335302540 0013082235

    Patients

    Seq Age Sex Outcome Treatment
    1