BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS (TM) SR PRO

    MDR report key: 2203504 · Received August 11, 2011

    Report

    Report Number
    2134265-2011-03306
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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 POST PERCUTANEOUS CORONARY INTERVENTION (PCI), A TIP DETACHMENT OCCURRED. THE ATLANTIS SR PRO IMAGING CATHETER WAS USED FOR A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE IN AN 80% STENOSED, MILDLY TORTUOUS AND CALCIFIED LESION. THE IMAGING CATHETER HAD DIFFICULTY CROSSING THE LESION. RESISTANCE WAS FELT DURING WITHDRAWAL OF THE IMAGING CATHETER AND THE DEVICE BECAME STUCK IN THE LESION. THE IMAGING CATHETER WAS SUCCESSFULLY REMOVED. THE TIP OF THE IMAGING CATHETER DETACHED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLANTIS (TM) SR PRO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT H749389420 14327093

    Patients

    Seq Age Sex Outcome Treatment
    1