BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTICROSS 18

    MDR report key: 21305330 · Received February 4, 2025

    Report

    Report Number
    2124215-2025-02343
    Event Type
    Injury
    Date Received
    February 4, 2025
    Date of Event
    January 8, 2025
    Report Date
    March 28, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729904366
    PMA / PMN Number
    K160514
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 - PREMARKET / 510(K): K160514, K222568. DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL ANALYSIS REVEALED THAT THE TIP WAS DETACHED, AND THE GUIDEWIRE EXIT PORT WAS DAMAGED. A KINK WAS OBSERVED IN THE TELESCOPE ASSEMBLY. MICROSCOPE INSPECTION ALSO IDENTIFIED THAT THE TIP AND THE GUIDEWIRE EXIT PORT WERE DETACHED. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TIP MARKERBAND DETACHMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE RIGHT COMMON ILIAC ARTERY. AN OPTICROSS 18 WAS SELECTED FOR USE. DURING REMOVAL OF THE CATHETER, IT WAS NOTED THAT THE TIP OF THE CATHETER WITH THE RADIOPAQUE PORTION WAS DETACHED AND STILL IN THE PATIENT. THE DETACHED PORTION WAS REMOVED WITH A SNARE AND THE ENTIRE DETACHED PORTION WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TIP MARKERBAND DETACHMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE RIGHT COMMON ILIAC ARTERY. AN OPTICROSS 18 WAS SELECTED FOR USE. DURING REMOVAL OF THE CATHETER, IT WAS NOTED THAT THE TIP OF THE CATHETER WITH THE RADIOPAQUE PORTION WAS DETACHED AND STILL IN THE PATIENT. THE DETACHED PORTION WAS REMOVED WITH A SNARE AND THE ENTIRE DETACHED PORTION WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65151 OPTICROSS 18 CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H7493932800180 0033928764 08714729904366

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention