BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTICROSS?

    MDR report key: 3934561 · Received July 15, 2014

    Report

    Report Number
    2134265-2014-04340
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR: 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

    IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE MILDLY TORTUOUS TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THREE NON BSC STENTS WERE DEPLOYED IN THE LESION AND THEN AN OPTICROSS¿ IMAGING CATHETER WAS ADVANCED TO PERFORM POST INTRAVASCULAR ULTRASOUND (IVUS). THE OPTICROSS¿ DEVICE GOT STUCK IN ONE OF THE NON-BSC STENTS AS IT WAS NOT FULLY APPOSED. THE PHYSICIAN WAS UNABLE TO PUSH/PULL THE IMAGING CATHETER. EVENTUALLY, THE GUIDEWIRE EXIT PORT KINKED. THE PHYSICIAN REMOVED THE DRIVE CABLE AND PLACED A NON-BSC GUIDEWIRE INTO THE CATHETER BUT THE DEVICE STILL COULD NOT BE REMOVED. THE PHYSICIAN ENGAGED ANOTHER NON-BSC GUIDE CATHETER AND INSERTED A NON-BSC BALLOON CATHETER AND DILATED TO THE POINT WHERE THE IMAGING CATHETER GOT STUCK. THE IMAGING CATHETER WAS THEN RELEASED AND REMOVED FROM THE PATIENT. IT WAS NOTED THAT THE STENT REMAINED IMPLANTED AND THERE WAS NO DAMAGE TO THE STENT. 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
    412024 OPTICROSS? CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (SUD) H749518080 16876400

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention STENT: NOBORI3.5/14MM| STENT: RESOLUTE INTEGRITY3.0/34MM| STENT: RESOLUTE INTEGRITY3.0/38MM