BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 4251452 · Received November 14, 2014

    Report

    Report Number
    2134265-2014-07224
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Report Date
    October 27, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    OBJ
    PMA / PMN Number
    K123621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2014-07162 AND 2134265-2014-07223. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. A 100V ILAB ULTRASOUND IMAGING SYSTEM WAS USED IN CONJUNCTION WITH AN OPTICROSS¿ IMAGING CATHETER TO VISUALIZE AN UNSPECIFIED VESSEL. DURING PERFORMING PULLBACK, THE NUMBERS DISPLAYED ON THE MONITOR CHANGED; HOWEVER, THE SLED FAILED TO MOVE. HENCE, AUTOMATIC PULLBACK FAILED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737846 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - COSTA RICA (COYOL) H749518080

    Patients

    Seq Age Sex Outcome Treatment
    1