BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHRO 14 "S" NEURO GUIDEWIRE

    MDR report key: 917077 · Received September 20, 2007

    Report

    Report Number
    6000078-2007-00236
    Event Type
    Injury
    Date Received
    September 20, 2007
    Date of Event
    August 20, 2007
    Report Date
    August 23, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    DQX
    PMA / PMN Number
    K032146
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR WAS NOTIFIED ON 09/18/2007 THAT AN USER FACILITY REPORT (REPORT # UNKNOWN) HAS BEEN FILED TO THE FDA ON THE RENEGADE CATHETER, WHICH WAS USED AS A CONCOMITANT MEDICAL PRODUCT DURING THIS EVENT'S PROCEDURE (PERFORMED IN 2007). ADD'L PMA/510 #: K023700, K002907.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO THE MANUFACTURER: DURING AN ATTEMPTED ARTERIOVENOUS MALFORMATION (AVM) COIL EMBOLIZATION PROCEDURE, 10CM OF THE GUIDEWIRE DISTAL TIP WAS DISLODGED FROM THE CATHETER AND BECAME LODGED IN THE ACA (ANTERIOR CEREBRAL ARTERY). "AN UNSUCCESSFUL ATTEMPT WAS MADE TO RETRIEVE THE BROKEN PIECE OF THE GUIDEWIRE WITH THE ALLIGATOR RETRIEVAL DEVICE. DURING THE USE OF THE ALLIGATOR RETRIEVAL DEVICE, THE TIP OF THE ALLIGATOR RETRIEVAL DEVICE BROKE OFF. THE PATIENT WAS SENT TO CRANIOTOMY SURGERY IN ORDER TO COMPLETE EMBOLIZATION OF THE AVM. MAJORITY OF THE GUIDEWIRE WAS REMOVED AT THIS TIME, BUT A PORTION OF THE GUIDEWIRE AND CATHETER REMAIN IN THE PATIENT'S LEFT INTERNAL CAROTID ARTERY. THE TIP OF THE ALLIGATOR RETRIEVAL DEVICE COULD NOT BE REMOVED, AND REMAINS IN THE PATIENT. PATIENT'S CURRENT CONDITION IS STABLE " [INFORMATION VERBALLY PROVIDED BY USER FACILITY RISK MANAGEMENT ON 09/07/2007].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO 14 "S" NEURO GUIDEWIRE DQX GUIDEWIRE DQX BOSTON SCIENTIFIC CORP. 1351

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention RENEGADE CATHETER