BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS

    MDR report key: 12232293 · Received July 27, 2021

    Report

    Report Number
    2134265-2021-09636
    Event Type
    Malfunction
    Date Received
    July 27, 2021
    Date of Event
    July 14, 2021
    Report Date
    September 15, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729841531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: VISUAL INSPECTION IDENTIFIED THAT THE DEVICE RETURN IN OPEN BOX WITH THE SEALED POUCH AND WITHOUT THE STERILE BAG. CORRECTION: B5 UPDATED TO: AFTER FURTHER REVIEW IS WAS DETERMINED THAT A CONTAMINATION ISSUE DID NOT OCCUR. THE USER REPORTED THAT THE STERILE SLEEVE FROM THE MOTOR DRIVE UNIT WAS NOT INSIDE THE PACKAGE. H6 DEVICE CODES: FROM: INCOMPLETE OR MISSING PACKAGING A020502, CONTAMINATION DURING USE A1801 TO: INCOMPLETE OR MISSING PACKAGING A020502.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CONTAMINATION ISSUE OCCURRED. THIS OPTICROSS IMAGING CATHETER WAS SELECTED FOR PREPARATION. HOWEVER; THE BOX DID NOT CONTAIN THE STERILE SLEEVE AND THIS CATHETER WAS UNABLE TO BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CONTAMINATION ISSUE OCCURRED. THIS OPTICROSS IMAGING CATHETER WAS SELECTED FOR PREPARATION. HOWEVER; THE BOX DID NOT CONTAIN THE STERILE SLEEVE AND THIS CATHETER WAS UNABLE TO BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131067 OPTICROSS CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION 8655 0027404460 08714729841531

    Patients

    Seq Age Sex Outcome Treatment
    1