BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 4200710 · Received October 24, 2014

    Report

    Report Number
    2134265-2014-06776
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 2014
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    OBJ
    PMA / PMN Number
    K123621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RECEIVED FOR EVALUATION. EVALUATION OF THE RETURNED DEVICE REVEALED THAT A KINK WAS OBSERVED IN THE TELESCOPE ASSEMBLY AT 65.0 CM FROM FEMORAL MARKER TO THE PROXIMAL END. THE TELESCOPE ASSEMBLY WAS NOT ABLE TO PULLBACK OR ADVANCE PROPERLY. 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. DURING IMAGE CHARACTERIZATION TESTING, NO IMAGE APPEARED IN THE SYSTEM DUE TO ELECTRICAL OPEN AT PROXIMAL. IMAGING CORE (IC) WINDUP IN THE TELESCOPE ASSEMBLY WAS OBSERVED DURING X-RAY ANALYSIS. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2014-06490, 2134265-2014-06686. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS, MILDLY CALCIFIED AND PRE DILATED DISTAL RIGHT CORONARY ARTERY. DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), AN OPTICROSS¿ IMAGING CATHETER WAS USED IN CONJUNCTION WITH AN ILAB ULTRASOUND IMAGING SYSTEM AND A GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SLED TO PERFORM AUTOMATIC PULLBACK. HOWEVER, IT WAS NOTED THAT THE TRANSDUCER OF THE OPTICROSS¿ IMAGING CATHETER COULD NOT BE MOVED. IT WAS ALSO NOTED THAT THE AUTOMATIC PULLBACK FAILED THUS THE TRANSDUCER COULD NOT BE RETURNED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2014-06490, 2134265-2014-06686. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS, MILDLY CALCIFIED AND PRE DILATED DISTAL RIGHT CORONARY ARTERY. DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), AN OPTICROSS¿ IMAGING CATHETER WAS USED IN CONJUNCTION WITH AN ILAB ULTRASOUND IMAGING SYSTEM AND A GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SLED TO PERFORM AUTOMATIC PULLBACK. HOWEVER, IT WAS NOTED THAT THE TRANSDUCER OF THE OPTICROSS¿ IMAGING CATHETER COULD NOT BE MOVED. IT WAS ALSO NOTED THAT THE AUTOMATIC PULLBACK FAILED THUS THE TRANSDUCER COULD NOT BE RETURNED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679674 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518100 17012017

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR BALLOON: MAVERICK 2.0X25