BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS¿ SR PRO²

    MDR report key: 3023553 · Received March 27, 2013

    Report

    Report Number
    2134265-2013-02201
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    DQO
    PMA / PMN Number
    K063312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED DEVICE REVEALED TWO FLAPS OF HUB ROTATOR WERE DAMAGED, IMAGING CORE WIND UP IN THE TELESCOPE ASSEMBLY AND THE TELESCOPE ASSEMBLY WAS NOT ABLE TO PROPERLY PULL BACK, ADVANCE, AND RETRACT. 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 DESIGN RELATED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#: 2134265-2013-02239 AND 2134265-2013-02238. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, IMAGING CATHETER WAS UNABLE TO BE PULLED BACK BY THE MOTORDRIVE UNIT OF THE ILAB IMAGING SYSTEM. THE 75% STENOSED TARGET LESION WAS LOCATED IN MILD TORTUOUS AND MILD CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A F/G ATLANTIS SR PRO² WAS USED FOR VISUALIZATION OF THE LESION. THE MOTORDRIVE UNIT (MDU) OF THE ILAB IMAGING SYSTEM WAS UNABLE TO PULL BACK THE IMAGING CATHETER. IMAGING CORE WINDUP OF THE IMAGING CATHETER WAS ALSO NOTICED. THE PROCEDURE WAS COMPLETED WITH THE SAME SLED AND MDU. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT IS IN GOOD CONDITION.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#: 2134265-2013-02239 AND 2134265-2013-02238. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, IMAGING CATHETER WAS UNABLE TO BE PULLED BACK BY THE MOTORDRIVE UNIT OF THE ILAB IMAGING SYSTEM. THE 75% STENOSED TARGET LESION WAS LOCATED IN MILD TORTUOUS AND MILD CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A F/G ATLANTIS SR PRO² WAS USED FOR VISUALIZATION OF THE LESION. THE MOTORDRIVE UNIT (MDU) OF THE ILAB IMAGING SYSTEM WAS UNABLE TO PULL BACK THE IMAGING CATHETER. IMAGING CORE WINDUP OF THE IMAGING CATHETER WAS ALSO NOTICED. THE PROCEDURE WAS COMPLETED WITH THE SAME SLED AND MDU. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT IS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127087 ATLANTIS¿ SR PRO² CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT (SUD) H749390140 15745077

    Patients

    Seq Age Sex Outcome Treatment
    1