BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS 6 HD

    MDR report key: 21286858 · Received January 31, 2025

    Report

    Report Number
    2124215-2025-03876
    Event Type
    Malfunction
    Date Received
    January 31, 2025
    Date of Event
    January 7, 2025
    Report Date
    March 27, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729960775
    PMA / PMN Number
    K173820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). G4: PREMARKET / 510(K) #: K213593.

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER ADDRESS 1:(B)(6). G4: PREMARKET / 510(K) #: K213593.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS HD IMAGING CATHETER WAS ADVANCED FOR AN INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE PHYSICIAN DID NOT CAPTURE LIVE IMAGES WHILE ADVANCING THE CATHETER AND ONLY RECORDED WHILE RETRACTING. THE PHYSICIAN ALSO ENCOUNTERED DIFFICULTY TRACKING THE CATHETER DURING REMOVAL, WHICH RESULTED IN THE IVUS CATHETER BECOMING ENTANGLED WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE. AS A RESULT, THE PHYSICIAN HAD TO PULL THE CATHETER AND GUIDEWIRE OUT TOGETHER AS A SINGLE UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS HD IMAGING CATHETER WAS ADVANCED FOR AN INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE PHYSICIAN DID NOT CAPTURE LIVE IMAGES WHILE ADVANCING THE CATHETER AND ONLY RECORDED WHILE RETRACTING. THE PHYSICIAN ALSO ENCOUNTERED DIFFICULTY TRACKING THE CATHETER DURING REMOVAL, WHICH RESULTED IN THE IVUS CATHETER BECOMING ENTANGLED WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE. AS A RESULT, THE PHYSICIAN HAD TO PULL THE CATHETER AND GUIDEWIRE OUT TOGETHER AS A SINGLE UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510995 OPTICROSS 6 HD CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H74939354080 0035124690 08714729960775

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown RUNTHROUGH TERUMO| RUNTHROUGH TERUMO