BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS 18

    MDR report key: 17293185 · Received July 10, 2023

    Report

    Report Number
    2124215-2023-36080
    Event Type
    Malfunction
    Date Received
    July 10, 2023
    Date of Event
    June 19, 2023
    Report Date
    September 1, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729904366
    PMA / PMN Number
    K160514
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT DEVICE WAS RECEIVED FOR PRODUCT ANALYSIS. VISUAL AND MICROSCOPIC EXAMINATION REVEALED A TWISTED IMAGING WINDOW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CATHETER TWISTING OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE POSTERIOR TIBIAL ARTERY (PTA). THE OPTICROSS PERIPHERAL IMAGING CATHETER WAS ADVANCED WITHOUT BEING PLUGGED INTO THE MOTOR DRIVE UNIT (MDU) FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. THE CATHETER WAS ATTACHED TO THE MDU AND IMAGING WAS ACQUIRED. PULLBACK WAS PERFORMED NORMALLY WITH IMAGING FROM THE PTA TO WHERE THE SHEATH WAS IN THE POPLITEAL ARTERY. THE MDU WAS THEN TURNED OFF AND THE CATHETER WAS ADVANCED BACK DOWN THE PTA FOR A CLOSER EXAMINATION OF THE STENOSIS. THE MDU WAS AGAIN TURNED ON AND AS THE CATHETER WAS BEING PULLED BACK TO THE LESION, IT IMMEDIATELY GRABBED THE WIRE AND WRAPPED INTO A TANGLED MESS. THE CATHETER AND WIRE WERE REMOVED TOGETHER AS A UNIT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CATHETER TWISTING OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE POSTERIOR TIBIAL ARTERY (PTA). THE OPTICROSS PERIPHERAL IMAGING CATHETER WAS ADVANCED WITHOUT BEING PLUGGED INTO THE MOTOR DRIVE UNIT (MDU) FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. THE CATHETER WAS ATTACHED TO THE MDU AND IMAGING WAS ACQUIRED. PULLBACK WAS PERFORMED NORMALLY WITH IMAGING FROM THE PTA TO WHERE THE SHEATH WAS IN THE POPLITEAL ARTERY. THE MDU WAS THEN TURNED OFF AND THE CATHETER WAS ADVANCED BACK DOWN THE PTA FOR A CLOSER EXAMINATION OF THE STENOSIS. THE MDU WAS AGAIN TURNED ON AND AS THE CATHETER WAS BEING PULLED BACK TO THE LESION, IT IMMEDIATELY GRABBED THE WIRE AND WRAPPED INTO A TANGLED MESS. THE CATHETER AND WIRE WERE REMOVED TOGETHER AS A UNIT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282379 OPTICROSS 18 CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION 44021 0031489042 08714729904366

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown COMMAND ES .014 GUIDEWIRE.| COMMAND ES .014 GUIDEWIRE.