BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS?

    MDR report key: 4200541 · Received October 24, 2014

    Report

    Report Number
    2134265-2014-06127
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 8, 2014
    Report Date
    October 6, 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

    (B)(4). THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DEVICE ANALYSIS REVEALED THAT THE LAP JOINT SECTION WAS DAMAGED WHEN THE DEVICE WAS RECEIVED. DURING HANDLING OF THE DEVICE DURING THE DECONTAMINATION PROCESS, THE IMAGING WINDOW BECAME DETACHED FROM THE BLUE SHEATH ASSEMBLY. NO DAMAGE WAS OBSERVED AT THE GUIDEWIRE EXIT PORT OR AT THE DISTAL TIP ASSEMBLY. NO KINKS WERE OBSERVED ALONG THE LENGTH OF THE CATHETER. THE TELESCOPE FEMALE TUBING WAS FOUND DETACHED FROM THE ANCHOR SEAL ASSEMBLY. THE TELESCOPE CANNOT ADVANCE THE TRANSDUCER DISTAL HOUSING (TDH) TO THE MOST DISTAL POSITION DUE TO THE DETACHMENTS. FULL IMAGE CHARACTERIZATION CANNOT BE PERFORMED DUE TO THE TELESCOPE AND IMAGING WINDOW DETACHMENT. THE DETACHMENT EXPOSES THE IMAGING CORE WHICH MIGHT ONSET A WINDUP WHEN A FUNCTIONAL TEST IS PERFORMED. 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 06OCT2014. IT WAS REPORTED THAT A CATHETER KINKED AND OUTER TELESCOPE TUBING DETACHMENT OCCURRED. DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), AN OPTICROSS¿ IMAGING CATHETER WAS SELECTED TO VISUALIZE AN UNSPECIFIED VESSEL. WHEN THE DEVICE WAS UNPACKED, IT WAS NOTED THAT THE GUIDEWIRE EXIT PORT WAS KINKED. FURTHERMORE, THE CONNECTION OF THE ANCHOR SEAL HOUSING WAS FOUND DETACHED WITHOUT ANY PHYSICIAN CONTACT ON THE DEVICE COMPONENT. MOREOVER, IT WAS ALSO NOTED THAT THE OUTER (FEMALE) TELESCOPE TUBING BETWEEN THE ANCHOR SEAL AND THE DISTAL STRAIN RELIEF OF THE DEVICE WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S CONDITION IS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE LAP JOINT SECTION OF THE DEVICE WAS DAMAGED AND A HOLE WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678608 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080 17153603

    Patients

    Seq Age Sex Outcome Treatment
    1