BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTICROSS 18

    MDR report key: 20857590 · Received December 5, 2024

    Report

    Report Number
    2124215-2024-73378
    Event Type
    Injury
    Date Received
    December 5, 2024
    Date of Event
    October 29, 2024
    Report Date
    December 5, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729904366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CATHETER ENTRAPMENT AND TIP DETACHMENT OCCURRED, REQUIRING SNARE FOR REMOVAL. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL. AN OPTICROSS 18 IMAGING CATHETER WAS SELECTED FOR LOWER EXTREMITY ANGIOGRAM. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER SPUN AROUND THE WIRE AND BROKE OFF INSIDE THE PATIENT'S BODY. THE BROKEN TIP WAS RECOVERED USING A NON-BOSTON SCIENTIFIC (BSC) SNARE, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1377235 OPTICROSS 18 CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H7493932800180 0034266425 08714729904366

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SNARE - MEDTRONIC GOOSENECK