BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTICROSS? 6 HD

    MDR report key: 23043361 · Received September 12, 2025

    Report

    Report Number
    2124215-2025-62959
    Event Type
    Injury
    Date Received
    September 12, 2025
    Date of Event
    August 20, 2025
    Report Date
    November 10, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729960775
    PMA / PMN Number
    K173820
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 PREMARKET / 510(K) #: K213593. VISUAL INSPECTION REVEALED THE TELESCOPE WAS KINKED AND THE TIP WAS KINKED AND DETACHED. THE TIP WAS NOT RETURNED. MICROSCOPIC AND MEDIA INSPECTION REVEALED THE TIP WAS KINKED, DETACHED, AND TORN.

    Additional Manufacturer Narrative · 0

    G4 PREMARKET / 510(K) #: K213593.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE OPTICROSS 6 HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. AFTER A SUCCESSFUL STENTING PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE IVUS CATHETER, RESISTANCE WAS ENCOUNTERED. PRESSURE WAS APPLIED TO WITHDRAW THE DEVICE, AND UPON REMOVAL, IT WAS NOTED THAT THE RADIOPAQUE MARKER AND DISTAL TIP HAD SHEARED OFF. THE LOCATION WAS INITIALLY UNCLEAR, AS THE MARKER WAS NOT VISIBLE ON FLUOROSCOPY. DURING CONTINUED INTERVENTION, THE RADIOPAQUE MARKER WAS OBSERVED IN THE LEFT MAIN CORONARY ARTERY. ATTEMPTS WERE MADE TO BALLOON DISTAL AND DRAG IT OUT WITH A SEMI-INFLATED BALLOON; HOWEVER, THE FINAL APPROACH WAS TO STENT IT INTO THE VESSEL WALL. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE OPTICROSS 6 HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. AFTER A SUCCESSFUL STENTING PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE IVUS CATHETER, RESISTANCE WAS ENCOUNTERED. PRESSURE WAS APPLIED TO WITHDRAW THE DEVICE, AND UPON REMOVAL, IT WAS NOTED THAT THE RADIOPAQUE MARKER AND DISTAL TIP HAD SHEARED OFF. THE LOCATION WAS INITIALLY UNCLEAR, AS THE MARKER WAS NOT VISIBLE ON FLUOROSCOPY. DURING CONTINUED INTERVENTION, THE RADIOPAQUE MARKER WAS OBSERVED IN THE LEFT MAIN CORONARY ARTERY. ATTEMPTS WERE MADE TO BALLOON DISTAL AND DRAG IT OUT WITH A SEMI-INFLATED BALLOON; HOWEVER, THE FINAL APPROACH WAS TO STENT IT INTO THE VESSEL WALL. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2180547 OPTICROSS? 6 HD CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H74939354080 0036624683 08714729960775

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention