BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS? SR PRO²

    MDR report key: 3241300 · Received July 22, 2013

    Report

    Report Number
    2134265-2013-05175
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 24, 2013
    Report Date
    July 1, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT THE 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; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 DURING A STENTING TREATMENT PROCEDURE, AN IMAGING CATHETER GOT STUCK WITH THE STENT. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS LEFT MAIN TRUNK CORONARY ARTERY. PRE-IVUS WAS PERFORMED AND A NON-BSC STENT WAS DEPLOYED. THE DEPLOYED STENT WAS POST-DILATED WITH AN NC QUANTUM APEX BALLOON CATHETER, THEN AN F/G ATLANTIS SR PRO² IMAGING CATHETER WAS USED FOR POST-IVUS. THE STENT WAS WELL APPOSED TO THE VESSEL WALL. DURING PULLBACK OF THE IMAGING CATHETER, RESISTANCE WAS FELT AND THE ATLANTIS WAS UNABLE TO BE REMOVED. THE PHYSICIAN THOUGHT THAT THE GUIDE WIRE EXIT PORT OF THE ATLANTIS CATHETER GOT STUCK WITH THE DISTAL EDGE OF THE STENT. THE PHYSICIAN ATTEMPTED TO REMOVE THE ATLANTIS USING AN UNKNOWN MICRO CATHETER AND A NON-BSC GUIDE WIRE BUT FAILED. THE ATLANTIS WAS SUCCESSFULLY REMOVED FROM THE PATIENT BY REMOVING THE TRANSDUCER CABLE FROM THE OUTERSHEATH AND INSERTING A 014 NON-BSC GUIDE WIRE FROM THE PROXIMAL INTO THE OUTERSHEATH OF THE ATLANTIS. POST DILATATION WAS PERFORMED USING AN NC QUANTUM APEX BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC IMAGING CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340400 ATLANTIS? SR PRO² CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT (SUD) H749390140 16006359

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDE WIRE: SION BLUE (ASAHI INTECC)| GUIDING CATHETER: LAUNCHER/7F JL4 (MEDTRONIC)| GUIDE WIRE: RUNTHROUGH (TERUMO)| INTRODUCER SHEATH: 7F SHEATH (TERUMO)| INFLATION DEVICE: EVEREST (MEDTRONIC)| STENT: RESOLUTE INTEGRITY (MEDTRONIC)