BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS? 6 HD

    MDR report key: 23696448 · Received December 2, 2025

    Report

    Report Number
    2124215-2025-87749
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    November 10, 2025
    Report Date
    December 2, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729960775
    PMA / PMN Number
    K173820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K) # K173820, K213593. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS 6 HD CATHETER WAS ADVANCED OVER A NON-BOSTON SCIENTIFIC GUIDEWIRE IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. UPON WITHDRAWAL, THE WIRE APPEARED TO HAVE BEEN CAPTURED BY THE ROTATION OF THE TRANSDUCER AND WRAPPED AROUND THE CATHETER. BOTH DEVICES WERE REMOVED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2753873 OPTICROSS? 6 HD CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H74939354080 0034195645 08714729960775

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BMW GUIDEWIRE - ABBOTT