BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTICROSS 6 HD

    MDR report key: 21349357 · Received February 10, 2025

    Report

    Report Number
    2124215-2025-06037
    Event Type
    Injury
    Date Received
    February 10, 2025
    Date of Event
    January 20, 2025
    Report Date
    February 25, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729960775
    PMA / PMN Number
    K173820
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 PREMARKET K213593

    Additional Manufacturer Narrative · 0

    G4, PMA/510K 213593. G2 REPORT SOURCE: CORRECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DISSECTION OCCURRED. THE PATIENT HAD TURNED DOWN CORONARY ARTERY BYPASS GRAFT MULTIPLE TIMES AND PRESENTED FOR MULTI VESSEL CORONARY ARTERY DISEASE PERCUTANEOUS CORONARY INTERVENTION (PCI). FOLLOWING BALLOON PREPARATION, A 4.00 SYNERGY STENT WAS IMPLANTED IN THE DISTAL CIRCUMFLEX ARTERY AND A 4.00 SYNERGY STENT WAS IMPLANTED IN THE PROXIMAL/OSTIAL CIRCUMFLEX. THE OPTICROSS 6 HD CATHETER WAS ADVANCED FOR BOTH PRE AND POST INTRAVASCULAR ULTRASOUND (IVUS) IMAGING TO OPTIMIZE THE CIRCUMFLEX. DUE TO THE ACUTE ANGLE OF THE CIRCUMFLEX AND THE NEWLY PLACED OSTIAL CIRCUMFLEX STENT, THE OPTICROSS WAS UNABLE TO CROSS. MULTIPLE ATTEMPTS WERE MADE TO ADVANCE THE OPTICROSS BUT THE DISTAL TIP WAS COMING IN CONTACT WITH THE OSTIAL EDGE OF THE STENT. WHEN THE PHYSICIAN CONTINUED TO TRY TO ADVANCE THE OPTICROSS, A LEFT MAIN FLOW-LIMITING DISSECTION OCCURRED CAUSING THE PATIENT TO EXPERIENCE CHEST PAIN. THE PATIENT WAS INTUBATED, BALLOON TAMPONADE WAS PERFORMED, AND A NON-BOSTON SCIENTIFIC HEART PUMP WAS IMPLANTED FOR SUPPORT. ANOTHER 4.00 SYNERGY STENT WAS IMPLANTED TO COVER THE LEFT MAIN DISSECTION. THE PATIENT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT FOR FURTHER EVALUATION AND TREATMENT. THE PATIENT WAS EXPECTED TO FULLY RECOVER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DISSECTION OCCURRED. THE PATIENT HAD TURNED DOWN CORONARY ARTERY BYPASS GRAFT MULTIPLE TIMES AND PRESENTED FOR MULTI VESSEL CORONARY ARTERY DISEASE PERCUTANEOUS CORONARY INTERVENTION (PCI). FOLLOWING BALLOON PREPARATION, A 4.00 SYNERGY STENT WAS IMPLANTED IN THE DISTAL CIRCUMFLEX ARTERY AND A 4.00 SYNERGY STENT WAS IMPLANTED IN THE PROXIMAL/OSTIAL CIRCUMFLEX. THE OPTICROSS 6 HD CATHETER WAS ADVANCED FOR BOTH PRE AND POST INTRAVASCULAR ULTRASOUND (IVUS) IMAGING TO OPTIMIZE THE CIRCUMFLEX. DUE TO THE ACUTE ANGLE OF THE CIRCUMFLEX AND THE NEWLY PLACED OSTIAL CIRCUMFLEX STENT, THE OPTICROSS WAS UNABLE TO CROSS. MULTIPLE ATTEMPTS WERE MADE TO ADVANCE THE OPTICROSS BUT THE DISTAL TIP WAS COMING IN CONTACT WITH THE OSTIAL EDGE OF THE STENT. WHEN THE PHYSICIAN CONTINUED TO TRY TO ADVANCE THE OPTICROSS, A LEFT MAIN FLOW-LIMITING DISSECTION OCCURRED CAUSING THE PATIENT TO EXPERIENCE CHEST PAIN. THE PATIENT WAS INTUBATED, BALLOON TAMPONADE WAS PERFORMED, AND A NON-BOSTON SCIENTIFIC HEART PUMP WAS IMPLANTED FOR SUPPORT. ANOTHER 4.00 SYNERGY STENT WAS IMPLANTED TO COVER THE LEFT MAIN DISSECTION. THE PATIENT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT FOR FURTHER EVALUATION AND TREATMENT. THE PATIENT WAS EXPECTED TO FULLY RECOVER. IT WAS FURTHER REPORTED THAT THE PATIENT RECOVERED AND HAS BEEN DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1708513 OPTICROSS 6 HD CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H74939354080 0035232549 08714729960775

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O| H