BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS¿ SR PRO²

    MDR report key: 2983452 · Received February 28, 2013

    Report

    Report Number
    2134265-2013-01053
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 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 TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE HUB TELESCOPE, IMAGING CORE, AND SOME PORTION OF THE SHEATH ASSEMBLY WERE MISSING AND NOT RECEIVED. THE DISTAL TIP END WAS CUT OFF WHEN RECEIVED. THE CUT OFF DISTAL TIP ASSEMBLY MEASURED 2.3CM LONG. KINKS WERE OBSERVED IN THE SHEATH ASSEMBLY AT 5.5CM, 7.0CM, 7.5CM, 9.8CM 13.4CM, 17.0CM AND 26.9CM FROM FEMORAL MARKER AT THE PROXIMAL END AND 6.7CM,12.3CM, 16.0CM, 17.5CM, AND 19.4CM AT THE DISTAL END. THE GUIDEWIRE EXIT PORT WAS LIFTED 1.0MM. NO BRITTLENESS WAS OBSERVED ON THE CUT OFF DISTAL TIP ASSEMBLY. THE BLACK SHEATH ASSEMBLY APPEARED STRETCHED, CRIMPED, AND TIED UP. NO STRETCH WAS OBSERVED IN THE IMAGING WINDOW ASSEMBLY. FULL IMAGE CHARACTERIZATION TESTING CANNOT BE PERFORMED BASED ON THE RETURNED CONDITION OF THE CATHETER. 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 OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL AND/OR PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2013-01054. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE AN IMAGING CATHETER BECAME STUCK IN THE STENT. THE 15MM IN LENGTH AND 2.50MM IN DIAMETER TARGET LESION BEING TREATED WAS LOCATED IN THE MODERATELY TORTUOUS MID TO APICAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. PREDILATION WAS PERFORMED WITH A 2.00X15M UNSPECIFIED BALLOON CATHETER. THE ATLANTIS IMAGING CATHETER WAS ADVANCED TO THE LAD AND PULLBACK WAS PERFORMED. A 2.25X20MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM WAS THEN ADVANCED TO THE LAD AND DEPLOYED AT 14 ATMOSPHERES. ADDITIONAL POST-DILATION WAS PERFORMED WITH THE STENT DELIVERY BALLOON TO 14 ATMOSPHERES. THE ATLANTIS IMAGING CATHETER WAS THEN PULLED BACK FOR POST-DEPLOYMENT IMAGING AND IMMEDIATELY BECAME STUCK IN THE PROMUS ELEMENT PLUS STENT. THE TWO DEVICES COULD NOT BE SEPARATED AFTER SEVERAL ATTEMPTS. AN UNSPECIFIED BALLOON CATHETER WAS THEN ADVANCED BUT WAS UNABLE TO CROSS THE ATLANTIS CATHETER AND PROMUS ELEMENT PLUS STENT. AN ADDITIONAL UNSPECIFIED GUIDE WIRE WAS THEN ADVANCED AND WAS ABLE TO CROSS THE TWO DEVICES, HOWEVER A BALLOON CATHETER WAS AGAIN ADVANCED AND WAS UNABLE TO CROSS THE STUCK DEVICES. THE PROMUS ELEMENT PLUS STENT BECAME DAMAGED AFTER THE ATLANTIS CATHETER BECAME STUCK WITHIN THE STENT. THE IMAGING CORE OF THE ATLANTIS CATHETER WAS THEN REMOVED LEAVING A PORTION OF THE DEVICE INSIDE OF THE PATIENT. A SUPPORT GUIDE WIRE WAS THEN ADVANCED IN AN ATTEMPT TO REMOVE THE STUCK DEVICES, HOWEVER IT WAS UNSUCCESSFUL. THE PATIENT WAS SENT TO SURGERY AND THE ATLANTIS CATHETER TIP WAS CUT OFF TO SEPARATE IT FROM THE PROMUS ELEMENT PLUS STENT AND BOTH DEVICES WERE REMOVED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2013-01054. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE AN IMAGING CATHETER BECAME STUCK IN THE STENT. THE 15MM IN LENGTH AND 2.50MM IN DIAMETER TARGET LESION BEING TREATED WAS LOCATED IN THE MODERATELY TORTUOUS MID TO APICAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. PREDILATION WAS PERFORMED WITH A 2.00X15M UNSPECIFIED BALLOON CATHETER. THE ATLANTIS IMAGING CATHETER WAS ADVANCED TO THE LAD AND PULLBACK WAS PERFORMED. A 2.25X20MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM WAS THEN ADVANCED TO THE LAD AND DEPLOYED AT 14 ATMOSPHERES. ADDITIONAL POST-DILATION WAS PERFORMED WITH THE STENT DELIVERY BALLOON TO 14 ATMOSPHERES. THE ATLANTIS IMAGING CATHETER WAS THEN PULLED BACK FOR POST-DEPLOYMENT IMAGING AND IMMEDIATELY BECAME STUCK IN THE PROMUS ELEMENT PLUS STENT. THE TWO DEVICES COULD NOT BE SEPARATED AFTER SEVERAL ATTEMPTS. AN UNSPECIFIED BALLOON CATHETER WAS THEN ADVANCED BUT WAS UNABLE TO CROSS THE ATLANTIS CATHETER AND PROMUS ELEMENT PLUS STENT. AN ADDITIONAL UNSPECIFIED GUIDE WIRE WAS THEN ADVANCED AND WAS ABLE TO CROSS THE TWO DEVICES, HOWEVER A BALLOON CATHETER WAS AGAIN ADVANCED AND WAS UNABLE TO CROSS THE STUCK DEVICES. THE PROMUS ELEMENT PLUS STENT BECAME DAMAGED AFTER THE ATLANTIS CATHETER BECAME STUCK WITHIN THE STENT. THE IMAGING CORE OF THE ATLANTIS CATHETER WAS THEN REMOVED LEAVING A PORTION OF THE DEVICE INSIDE OF THE PATIENT. A SUPPORT GUIDE WIRE WAS THEN ADVANCED IN AN ATTEMPT TO REMOVE THE STUCK DEVICES, HOWEVER IT WAS UNSUCCESSFUL. THE PATIENT WAS SENT TO SURGERY AND THE ATLANTIS CATHETER TIP WAS CUT OFF TO SEPARATE IT FROM THE PROMUS ELEMENT PLUS STENT AND BOTH DEVICES WERE REMOVED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86267 ATLANTIS¿ SR PRO² CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT (SUD) H749390140 15650977

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention