BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTICROSS?

    MDR report key: 3851432 · Received June 5, 2014

    Report

    Report Number
    2134265-2014-03074
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 8, 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

    (B)(4). DEVICE EVALUATED BY MFR:THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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

    SAME CASE AS 2134265-2014-03573. IT WAS REPORTED THAT THE IMAGING CATHETER GOT STUCK IN THE STENT. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. PREDILATATION WAS PERFORMED USING AN UNSPECIFIED BALLOON CATHETER. AN UNSPECIFIED SIZE PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM WAS IMPLANTED TO TREAT THE LESION. IT WAS CONFIRMED THAT THE STENT WAS APPOSED TO THE TARGET LESION. POST-IVUS WAS PERFORMED USING AN OPTICROSS IMAGING CATHETER TO VISUALIZE THE STENT. WHEN THE PHYSICIAN PULLED THE IMAGING CATHETER, IT WAS NOTED THAT AN UNSPECIFIED GUIDE WIRE GOT ENTANGLED WITH THE STENT. SUBSEQUENTLY, THE GUIDE WIRE EXIT HOLE OF THE IMAGING CATHETER GOT STUCK WITH THE DISTAL END OF THE STENT. IT WAS THEN NOTED THAT THE STENT WAS SHORTENED. ANOTHER UNSPECIFIED GUIDE WIRE WAS READVANCED. DILATATION WAS PERFORMED USING AN UNSPECIFIED BALLOON CATHETER. AN UNSPECIFIED STENT WAS IMPLANTED TO COVER THE SHORTENED PART OF THE PREVIOUSLY IMPLANTED STENT. THE IMAGING CATHETER AND THE UNSPECIFIED GUIDE WIRE WERE REMOVED FROM THE PATIENT'S BODY. THE COMPLAINANT CLAIMED THAT THE DEVICES ARE LIKELY TO GET STUCK AT THE GUIDE WIRE EXIT HOLE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329193 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080 16817210

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention