BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 4243548 · Received November 11, 2014

    Report

    Report Number
    2134265-2014-06821
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    September 1, 2014
    Report Date
    October 20, 2014
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    OBJ
    PMA / PMN Number
    K123621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). THE COMPLAINT DEVICE WAS RECEIVED FOR EVALUATION. EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE IMAGING WINDOW WAS DETACHED FROM THE BLUE SHEATH ASSEMBLY AT THE LAP JOINT WHEN RECEIVED. SINCE THE TELESCOPE CANNOT ADVANCE THE TRANSDUCER DISTAL HOUSING (TDH) TO THE MOST DISTAL POSITION DUE TO THE DETACHMENT, THE DISTANCE FROM THE DISTAL END OF THE TRANSDUCER HOUSING TO THE TIP OF THE CATHETER WAS NOT MEASURED. DURING IMPEDANCE TESTING, ELECTRICAL OPEN AT PROXIMAL WAS OBSERVED. IMAGING CORE WIND UP IN THE TELESCOPE ASSEMBLY WAS OBSERVED DURING X-RAY ANALYSIS. THE DRIVE SHAFT-IMAGING CORE WAS FOUND BROKEN AT THE HUB. NO OTHER ISSUES OR DEFECTS WERE OBSERVED DURING PRODUCT ANALYSIS OF THE RETURNED DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED DIFFICULTY IS A DESIGN CONSTRAINT OF THE PRODUCT. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20OCT2014. IT WAS REPORTED THAT LOSS OF IMAGE HAS OCCURRED. DURING A PERCUTANEOUS CORONARY INTERVENTION, AN OPTICROSS¿ IMAGING CATHETER WAS USED TO DIAGNOSE AN UNKNOWN LESION LOCATED AT THE LEFT ANTERIOR DESCENDING ARTERY. WHEN THE DEVICE WAS USED INSIDE THE PATIENT, IMAGE WAS LOST. THE PHYSICIAN CONFIRMED THAT NO SEPARATION WAS OBSERVED WITH THE DEVICE AFTER REMOVING IT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WITH SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION IS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE IMAGING WINDOW WAS DETACHED FROM THE BLUE SHEATH ASSEMBLY AT THE LAP JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726903 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080 17156595

    Patients

    Seq Age Sex Outcome Treatment
    1