BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC IMAGING CATHETER - CORONARY

    MDR report key: 2920516 · Received January 17, 2013

    Report

    Report Number
    2134265-2013-00311
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 25, 2012
    Report Date
    December 25, 2012
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    DQO
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, 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

    SAME CASE AS MFR #:2134265-2012-08541 AND 2134265-2013-00288. IT WAS REPORTED THAT DURING PREPARATION FOR AN UNSPECIFIED PROCEDURE THE MOTOR DRIVE FAILED TO PULLBACK. THE TARGET LESION WAS LOCATED IN AN UNKNOWN VESSEL. THE SYSTEM DISPLAYED AN ACQUISITION PC CONNECTION FAILURE MESSAGE (ERROR 119) AND MOTOR DRIVE PULLBACK UNEXPECTEDLY STOPPED. THE SYSTEM WAS REBOOTED AND DISPLAYED A NO SIGNAL MESSAGE AND DID NOT BOOT INTO THE APPLICATION. THE IMAGE AND ACQUISITION PCS WERE REBOOTED AND THE SYSTEM DISPLAYED AN ACQUISITION PC CONNECTION FAILURE MESSAGE (ERROR 119). THE EVENT OCCURRED OUTSIDE OF THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION IS GOOD.

    Description of Event or Problem · 1

    SAME CASE AS MFR #:2134265-2012-08541 AND 2134265-2013-00288. IT WAS REPORTED THAT DURING PREPARATION FOR AN UNSPECIFIED PROCEDURE THE MOTOR DRIVE FAILED TO PULLBACK. THE TARGET LESION WAS LOCATED IN AN UNKNOWN VESSEL. THE SYSTEM DISPLAYED AN ACQUISITION PC CONNECTION FAILURE MESSAGE (ERROR 119) AND MOTOR DRIVE PULLBACK UNEXPECTEDLY STOPPED. THE SYSTEM WAS REBOOTED AND DISPLAYED A NO SIGNAL MESSAGE AND DID NOT BOOT INTO THE APPLICATION. THE IMAGE AND ACQUISITION PCS WERE REBOOTED AND THE SYSTEM DISPLAYED AN ACQUISITION PC CONNECTION FAILURE MESSAGE (ERROR 119). THE EVENT OCCURRED OUTSIDE OF THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25676 ULTRASONIC IMAGING CATHETER - CORONARY CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT (SUD) UNK97

    Patients

    Seq Age Sex Outcome Treatment
    1