BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTICROSS?

    MDR report key: 3983049 · Received August 6, 2014

    Report

    Report Number
    2134265-2014-04588
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    OBJ
    PMA / PMN Number
    K123621
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: 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

    IT WAS REPORTED THAT A VESSEL DISSECTION OCCURRED. ACCESS WAS OBTAINED VIA UNSPECIFIED VESSEL ON THE LEFT LEG. THE TARGET LESION WAS LOCATED IN THE 80% STENOSED LEFT ANTERIOR DESCENDING (LAD) AND LEFT MAIN ARTERIES. DURING THE PROCEDURE, AN OPTICROSS IMAGING CATHETER FAILED TO GO OVER THE UNSPECIFIED GUIDEWIRE AFTER SEVERAL ATTEMPTS. THE PHYSICIAN THEN GRABBED ANOTHER OPTICROSS¿ IMAGING CATHETER TO CHECK THE VESSEL. MOREOVER, THE PHYSICIAN TRIED TO DRIVE THE DEVICE, BUT THE IMAGE KEPT BLACKING OUT. THE DEVICE WAS FLUSHED AND PREPPED, HOWEVER, IMAGE FAILED TO APPEAR. A DISSECTION IN THE LEFT MAIN ARTERY WAS NOTED. THE DEVICE WAS THEN REMOVED AND EXCHANGED WITH A THIRD OPTICROSS IMAGING CATHETER WHICH ALSO FAILED TO TRACK INTO THE UNSPECIFIED GUIDEWIRE. THE PROCEDURE WAS COMPLETED USING A FOURTH OPTICROSS IMAGING CATHETER AND UNSPECIFIED STENTS WERE DEPLOYED IN THE LAD AND LEFT MAIN ARTERIES. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460904 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518110

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention