BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTICROSS?

    MDR report key: 3870127 · Received June 12, 2014

    Report

    Report Number
    2134265-2014-03426
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 15, 2014
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    OBJ
    PMA / PMN Number
    K123621
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED TO MFR: THE DEVICE WAS RETURNED FOR EVALUATION. EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE IMAGING CORE ROTATING COMPONENTS, IMAGING CORE AND RETAINER CLIP FROM INSIDE THE HUB WERE MISSING. ONLY THE HUB, TELESCOPE, SHEATH, IMAGING WINDOW AND TIP WAS RETURNED. THE GUIDEWIRE EXIT PORT WAS LIFTED. A TEST GUIDEWIRE (0.014") WAS INSERTED AND NO INDICATION OF RESISTANCE IN TRACKING THE GUIDEWIRE INTO THE CATHETER WAS NOTED. A 0.011" GUIDEWIRE WAS FOUND STUCK IN THE DEVICE. IT WAS COMING OUT FROM THE INNER TELESCOPE TUBING OUT OF THE HUB. SINCE THE IMAGING CORE WAS MISSING, THE DISTANCE FROM THE DISTAL END OF THE TRANSDUCER HOUSING TO THE TIP OF THE CATHETER CAN NOT MEASURED. KINKS WERE OBSERVED IN THE TIP ASSEMBLY. BLOOD WAS FOUND TRAPPED IN THE TELESCOPE AND HUB FLUSH PORT. FULL IMAGE CHARACTERIZATION TESTING CANNOT BE PERFORMED BASED ON THE RETURNED CONDITION OF THE CATHETER. 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 IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER GOT STUCK IN THE CORONARY ARTERY. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED PROXIMAL OF THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A NON-BSC STENT WAS IMPLANTED TO TREAT THE TARGET LESION. INTRAVASCULAR ULTRASOUND WAS THEN PERFORMED USING AN OPTICROSS IMAGING CATHETER. DURING MANIPULATION, THE IMAGING CATHETER GOT STUCK WITH THE STENT AND IT WAS DIFFICULT TO BE PULLED OUT. THE PHYSICIAN THOUGHT THAT THE NON-BSC STENT WAS NOT FULLY DEPLOYED AND CAUSED THE EVENT. SUBSEQUENTLY, A 2.00MM X 15MM EMERGE BALLOON CATHETER WAS USED TO REMOVE THE IMAGING CATHETER. DILATATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON CATHETER AFTER THE IMAGING CATHETER WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER GOT STUCK IN THE CORONARY ARTERY. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED PROXIMAL OF THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A NON-BSC STENT WAS IMPLANTED TO TREAT THE TARGET LESION. INTRAVASCULAR ULTRASOUND WAS THEN PERFORMED USING AN OPTICROSS¿ IMAGING CATHETER. DURING MANIPULATION, THE IMAGING CATHETER GOT STUCK WITH THE STENT AND IT WAS DIFFICULT TO BE PULLED OUT. THE PHYSICIAN THOUGHT THAT THE NON-BSC STENT WAS NOT FULLY DEPLOYED AND CAUSED THE EVENT. SUBSEQUENTLY, A 2.00MM X 15MM EMERGE¿ BALLOON CATHETER WAS USED TO REMOVE THE IMAGING CATHETER. DILATATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON CATHETER AFTER THE IMAGING CATHETER WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347970 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080 16814906

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention