BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 4093355 · Received September 16, 2014

    Report

    Report Number
    2134265-2014-05477
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    June 30, 2014
    Report Date
    August 21, 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). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. EVALUATION OF THE RETURNED DEVICE REVEALED THAT A KINK WAS OBSERVED IN THE SHEATH ASSEMBLY AT 12.0 CM FROM FEMORAL MARKER AT THE DISTAL END. THE TELESCOPE ASSEMBLY WAS NOT ABLE TO PROPERLY PULL BACK, ADVANCE, OR RETRACT. SINCE THE TELESCOPE CANNOT ADVANCE THE TRANSDUCER DISTAL HOUSING (TDH) TO THE MOST DISTAL POSITION, THE DISTANCE FROM THE DISTAL END OF THE TRANSDUCER HOUSING TO THE TIP OF THE CATHETER WAS NOT MEASURED. AN OPEN HOLE WAS OBSERVED AT THE SHEATH LAP JOINT SECTION OF THE DEVICE. FLUID WAS LEAKING FROM THE OPEN HOLE AT THE SHEATH LAP JOINT ASSEMBLY WHEN THE CATHETER WAS FLUSHED. THE IMAGING WINDOW WAS STILL CONNECTED TO THE BLUE SHEATH TUBING AT THE LAP JOINT. IMPEDANCE TESTING FINDS THAT THERE WAS NO ELECTRICAL DISCONNECT IN THE IMAGING CIRCUIT. FULL IMAGE CHARACTERIZATION CANNOT BE PERFORMED DUE TO THE HOLE AT THE LAP JOINT SEAM BETWEEN THE IMAGING WINDOW AND BLUE SHEATH TUBING. THIS HOLE PREVENTS THE DEVICE TO BE FLUSHED PROPERLY AND IT TENDS TO BEND A LITTLE THAT COULD INTERFERE WITH THE PROPER ROTATION OF THE IMAGING CORE. 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 WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT THE CATHETER WAS KINKED AND HAD A HOLE. DURING PREPARATION FOR PERCUTANEOUS CORONARY INTERVENTION (PCI), IT WAS NOTED THAT THE CONNECTING SECTION OF THE OPTICROSS¿ IMAGING CATHETER, ON THE PROXIMAL SHAFT OF THE TELESCOPE AND THE SHEATH, WAS KINKED AND HAD A HOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED A HOLE AT THE SHEATH LAP JOINT AREA OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571825 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080 17013022

    Patients

    Seq Age Sex Outcome Treatment
    1