BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELSIOR SL-10 PRE-SHAPED CATHETER

    MDR report key: 873264 · Received September 14, 2006

    Report

    Report Number
    6000078-2006-00424
    Event Type
    Malfunction
    Date Received
    September 14, 2006
    Date of Event
    August 28, 2006
    Report Date
    August 28, 2006
    Manufacturer
    NEUROVASCULAR, A DIV. OF BOSTON SCIENTIFIC CORP
    Product Code
    DQO
    PMA / PMN Number
    K013789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION HAS NOT YET BEEN RETURNED TO BOSTON SCIENTIFIC FOR FURTHER INVESTIGATION. THEREFORE, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. IF THE DEVICE IS RETURNED, AND FURTHER SIGNIFICANT INFO IS FOUND, A SUPPLEMENTAL REPORT WILL FOLLOW. ADD'L 510(K) # K042568/ K994155.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED FLUSHING WAS DIFFICULT AT PREPARATION AS ONLY A FEW DROPS OF SALINE FELL FROM THE DISTAL TIP. FLUSHING WAS PERFORMED AGAIN WITHOUT INCIDENT. THE CATHETER WAS THEN ADVANCED TO A VERY TORTUOUS LESION AT THE ANTERIOR OF THE SPINAL ARTERY. THE PHYSICIAN THEN INSERTED A DETACHABLE COIL AND REPORTEDLY FELT A LOT OF RESISTANCE. THE COIL WAS REMOVED AND FLUSHED AGAIN WITH ONLY A FEW DROPS OF SALINE COMING FROM THE TIP AGAIN. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER SIMILAR DEVICE. THERE WAS NO ALLEGATION OF HARM. THE PHYSICIAN ALSO NOTED THAT CONTINUOUS FLUSHED WAS MAINTAINED THROUGHOUT THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELSIOR SL-10 PRE-SHAPED CATHETER INFUSION CATHETER DQO NEUROVASCULAR, A DIV. OF BOSTON SCIENTIFIC CORP 168190 8468956

    Patients

    Seq Age Sex Outcome Treatment
    1 * GDC DETACHABLE COIL (MODEL # UNK)