BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTICROSS? HD

    MDR report key: 22420719 · Received July 7, 2025

    Report

    Report Number
    2124215-2025-45015
    Event Type
    Injury
    Date Received
    July 7, 2025
    Date of Event
    June 1, 2025
    Report Date
    September 3, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729960737
    PMA / PMN Number
    K173284
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT WAS ESTIMATED BASED ON AWARE DATE AS THE EVENT DATE WAS NOT REPORTED. G4: PMA/510(K) # K173284, K213593. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE THE DEVICE STATUS, BUT IT WAS UNABLE TO BE OBTAINED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL EVALUATION COULD NOT BE PERFORMED. HOWEVER, A REVIEW OF THE MEDIA PROVIDED BY THE CUSTOMER SHOWED EVIDENCE THAT THE TIP WAS DETACHED.

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT WAS ESTIMATED BASED ON AWARE DATE AS THE EVENT DATE WAS NOT REPORTED. G4: PMA/510(K) # K173284, K213593. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE THE DEVICE STATUS, BUT IT WAS UNABLE TO BE OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE POST STENT PLACEMENT IVUS RUN, THE TIP OF THE CATHETER BROKE OFF INSIDE THE PATIENT. COMPUTER TOMOGRAPHY (CT) WAS PERFORMED BUT THE CATHETER TIP WAS NOT SHOWN. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS FINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE POST STENT PLACEMENT IVUS RUN, THE TIP OF THE CATHETER BROKE OFF INSIDE THE PATIENT. COMPUTER TOMOGRAPHY (CT) WAS PERFORMED BUT THE CATHETER TIP WAS NOT SHOWN. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7840 OPTICROSS? HD CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H74939352040 0035668521 08714729960737

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown