BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRO-14 NEURO GUIDEWIRE

    MDR report key: 756245 · Received July 28, 2006

    Report

    Report Number
    6000078-2006-00337
    Event Type
    Malfunction
    Date Received
    July 28, 2006
    Date of Event
    March 21, 2006
    Report Date
    March 22, 2006
    Manufacturer
    NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORP
    Product Code
    DQX
    PMA / PMN Number
    K032146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS NOT RETURNED TO THE MFR. ATTEMPTS TO RETRIEVE THE DEVICE AND ADD'L INFO WERE UNSUCCESSFUL. A DEVICE HISTORY RECORD (DHR) REVIEW AND A SIMILAR COMPLAINTS REVIEW WAS PERFORMED AS PART OF THE DEVICE EVALUATION. THE DHR REVIEW SHOWED ON ISSUES OR DISCREPANCIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE SIMILAR COMPLAINTS REVIEW ON THE BATCH REVEALED NO OTHER COMPLAINTS LISTED ON THIS BATCH. A REVIEW OF SIMILAR COMPLAINTS FOR THE PRODUCT MODEL NUMBER REVEALED ADD'L COMPLAINTS. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) HAS BEEN ISSUED FOR THIS DEFECT TYPE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. BASED ON THE INFO KNOWN AT THIS TIME, BOSTON SCIENTIFIC CANNOT CONFIRM THE USER'S COMPLAINT, AND CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. IF THE DEVICE IN QUESITON IS RETURNED OR IF FURTHER SIGNIFICANT INFO IS FOUND, A SUPPLEMENTAL REPORT WILL FOLLOW. PMA/510 (K) - K023700, K002907.

    Description of Event or Problem · 1

    THE HOSP REPORTED AN ANEURYSM COILING PROCEDURE IN THE BRAIN. AFTER EXPERIENCING FRICTION WITH THE FIRST DEVICE IN QUESTION, THE PROCEDURE WAS ATTEMPTED AGAIN WITH THE DEVICE IN QUESTION (DIFFERENT LOT NUMBER THAN THE FIRST DEVICE). FRICTION WAS FELT AGAIN. UPON REMOVAL OF THE DEVICE IN QUESTION FROM THE CATHETER, THERE WAS A BUILD UP OF FOREIGN MATTER, AS IF THE COATING WAS COMING OFF. THE HOSP REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE, THAT THE PT HAD NO COMPLICATIONS, AND THAT THE PT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO-14 NEURO GUIDEWIRE GUIDEWIRE DQX NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORP 1301 # B07325

    Patients

    Seq Age Sex Outcome Treatment
    1 * SYNCHRO GUIDEWIRE
    2