BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS 18

    MDR report key: 22393939 · Received July 3, 2025

    Report

    Report Number
    2124215-2025-43958
    Event Type
    Malfunction
    Date Received
    July 3, 2025
    Date of Event
    June 12, 2025
    Report Date
    August 13, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729904366
    PMA / PMN Number
    K160514
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K) # K160514, K222568.

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K) # K160514, K222568. THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION REVEALED NO ISSUES, AND THE DEVICE APPEARED TO BE IN GOOD CONDITION. THE NON-BOSTON SCIENTIFIC GUIDEWIRE WAS NOT RETURNED FOR ANALYSIS. MICROSCOPIC INSPECTION REVEALED THAT THE GUIDEWIRE EXIT PORT WAS LIFTED, BUT THE DISTAL SECTION OF THE TIP WAS IN GOOD CONDITION. A TEST GUIDEWIRE WAS INSERTED, AND THERE WAS NO INDICATION OF RESISTANCE WHEN TRACKING THE GUIDEWIRE INTO THE CATHETER.

    Description of Event or Problem · 0

    A CATHETER ISSUE WAS REPORTED DURING THE PROCEDURE. THE 90% STENOSED TARGET LESION WAS LOCATED IN A LIMITED TORTUOUS, AND MILDLY CALCIFIED MID SUPERFICIAL FEMORAL ARTERY (SFA). AN OPTICROSS 18 IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE CATHETER DEPLOYED TO POSITION BUT WRAPPED AROUND A NON-BOSTON SCIENTIFIC (NON-BSC) WIRE DURING RECORDING PULLBACK. THE CATHETER WAS THEN PULLED OUT ALONG WITH THE NON-BSC WIRE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    A CATHETER ISSUE WAS REPORTED DURING THE PROCEDURE. THE 90% STENOSED TARGET LESION WAS LOCATED IN A LIMITED TORTUOUS, AND MILDLY CALCIFIED MID SUPERFICIAL FEMORAL ARTERY (SFA). AN OPTICROSS 18 IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE CATHETER DEPLOYED TO POSITION BUT WRAPPED AROUND A NON-BOSTON SCIENTIFIC (NON-BSC) WIRE DURING RECORDING PULLBACK. THE CATHETER WAS THEN PULLED OUT ALONG WITH THE NON-BSC WIRE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1884247 OPTICROSS 18 CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H7493932800180 0036158498 08714729904366

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SPARTACORE WIRE.| SPARTACORE WIRE.