BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS? HD

    MDR report key: 21470324 · Received February 26, 2025

    Report

    Report Number
    2124215-2025-08812
    Event Type
    Malfunction
    Date Received
    February 26, 2025
    Date of Event
    January 21, 2025
    Report Date
    April 8, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    PMA / PMN Number
    K173284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE ANALYSIS WAS DONE ON THE MEDIA RETURNED BY THE CUSTOMER, AND IT DOES NOT SHOW EVIDENCE OF THE REPORTED ISSUE. G4:PREMARKET / 510(K) # K173284, K213593.

    Additional Manufacturer Narrative · 0

    G4: PMA/510K. K213593.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN MODERATELY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. THE OPTICROSS HD CATHETER WAS INTRODUCED OVER A NON-BOSTON SCIENTIFIC GUIDEWIRE FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. WHEN THE OPTICROSS WAS ADVANCED INTO THE LESION, RESISTANCE WAS ENCOUNTERED. IMAGING WAS TURNED ON WITHOUT A SLED AND DURING MANUAL PULLBACK, AN IMAGE WAS SEEN. RESISTANCE WAS FELT AND WHEN THE DEVICE WAS PULLED, IT COULD NOT BE REMOVED. IMAGING WAS TURNED OFF AND THE OPTICROSS AND GUIDEWIRE WERE REMOVED TOGETHER AS ONE UNIT. IT WAS NOTED THAT THE GUIDEWIRE WAS WRAPPED AROUND THE OPTICROSS AND THE DISTAL SHAFT OF THE OPTICROSS WAS KINKED. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICES. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN MODERATELY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. THE OPTICROSS HD CATHETER WAS INTRODUCED OVER A NON-BOSTON SCIENTIFIC GUIDEWIRE FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. WHEN THE OPTICROSS WAS ADVANCED INTO THE LESION, RESISTANCE WAS ENCOUNTERED. IMAGING WAS TURNED ON WITHOUT A SLED AND DURING MANUAL PULLBACK, AN IMAGE WAS SEEN. RESISTANCE WAS FELT AND WHEN THE DEVICE WAS PULLED, IT COULD NOT BE REMOVED. IMAGING WAS TURNED OFF AND THE OPTICROSS AND GUIDEWIRE WERE REMOVED TOGETHER AS ONE UNIT. IT WAS NOTED THAT THE GUIDEWIRE WAS WRAPPED AROUND THE OPTICROSS AND THE DISTAL SHAFT OF THE OPTICROSS WAS KINKED. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICES. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327318 OPTICROSS? HD CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H74939352040 0033263719

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TERUMO RUNTHROUGH GUIDEWIRE 190 CM| TERUMO RUNTHROUGH GUIDEWIRE 190 CM