BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTICROSS? HD

    MDR report key: 24061421 · Received January 13, 2026

    Report

    Report Number
    2124215-2026-02280
    Event Type
    Injury
    Date Received
    January 13, 2026
    Date of Event
    November 21, 2025
    Report Date
    April 21, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729960737
    PMA / PMN Number
    K173284
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PREMARKET / 510(K) #: K173284, K213593. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA USER MED WATCH MW5179642 THAT TIP DETACHMENT OCCURRED. A PATIENT WAS ADMITTED FOR A SCHEDULED CORONARY ANGIOGRAM TO EVALUATE FOR OBSTRUCTIVE CORONARY ARTERY DISEASE DUE TO UNSTABLE ANGINA AND AN ELEVATED CORONARY ARTERY CALCIUM SCORE. SEVERE DISEASE WAS FOUND IN THE LEFT CIRCUMFLEX ARTERY (LCX), AND PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH A SINGLE DRUG-ELUTING STENT (DES) WAS PERFORMED. THE OPTICROSS HD IMAGING CATHETER WAS USED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. AFTER THE LAST IMAGING RUN, A SMALL PART OF THE CATHETER TIP (ABOUT 4 MM) BROKE OFF AND REMAINED IN THE VERY DISTAL LCX. THE VESSEL WAS HIGHLY TORTUOUS AND CALCIFIED, MAKING RETRIEVAL DIFFICULT. THE PHYSICIAN DECIDED NOT TO ATTEMPT SNARING BECAUSE OF THE RISK AND LOCATION AND INSTEAD USED A WIRE TO PUSH THE BROKEN PIECE FURTHER DOWN INTO THE DISTAL OBTUSE MARGINAL BRANCH TO MINIMIZE RISK. THE PATIENT WAS MONITORED FOR RECURRENT CEREBRAL PALSY. IT WAS REPORTED SYMPTOMS IMPROVED AND THE PATIENT WAS DISCHARGED HOME WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123427 OPTICROSS? HD CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H74939352040 0037168929 08714729960737

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention