BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS 6 HD

    MDR report key: 21698060 · Received March 26, 2025

    Report

    Report Number
    2124215-2025-18675
    Event Type
    Malfunction
    Date Received
    March 26, 2025
    Date of Event
    March 1, 2025
    Report Date
    May 2, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729960775
    PMA / PMN Number
    K173820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT WAS ESTIMATED BASED ON AWARE DATE AS THE EVENT DATE WAS NOT PROVIDED. G4 PREMARKET / 510(K): K173820, K213593. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED. THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION REVEALED NO ISSUES, AND THE DEVICE APPEARS TO BE IN GOOD CONDITION. MICROSCOPIC INSPECTION REVEALED THE GUIDEWIRE EXIT PORT WAS TORN BUT THE DISTAL SECTION OF THE TIP WAS IN GOOD CONDITION. A TEST GUIDEWIRE WAS INSERTED AND NO INDICATION OF RESISTANCE IN TRACKING THE GUIDEWIRE INTO THE CATHETER WAS NOTED.

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT WAS ESTIMATED BASED ON AWARE DATE AS THE EVENT DATE WAS NOT PROVIDED. G4 PREMARKET / 510(K): K173820, K213593. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS 6 HD IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE CATHETER GOT STUCK WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS 6 HD IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE CATHETER GOT STUCK WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066667 OPTICROSS 6 HD CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H74939354080 0035399117 08714729960775

    Patients

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