BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS? 018

    MDR report key: 3132897 · Received May 29, 2013

    Report

    Report Number
    2134265-2013-03673
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    ITX
    PMA / PMN Number
    K073623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. IT WAS OBSERVED THAT TWO FLAPS OF HUB ROTATOR WERE DAMAGED. THE UNIT WAS ABLE TO CONNECT INTO MDU SYSTEM PROPERLY. THE RETURNED DEVICE WAS MISSING A PORTION OF THE TIP FROM THE RO MARKER. THE TIP APPEARED TO HAVE BEEN STRETCHED AND THE RO MARKER APPEARED TO MOVE OUT OF PLACE DUE TO THE STRETCHING. THE MISSING PORTION OF THE TIP WAS NOT RETURNED. THERE WAS NO DAMAGE OBSERVED ON THE GUIDEWIRE EXIT PORT ASSEMBLY. A TEST GUIDEWIRE ((B)(4)) WAS INSERTED AND NO INDICATION OF RESISTANCE IN TRACKING THE GUIDEWIRE INTO THE CATHETER WAS NOTED. DURING IMAGE CHARACTERIZATION TESTING IN THE ROLLER COASTER MODEL, A GOOD SQUARE IMAGE APPEARED IN THE SYSTEM AND THE PRODUCT PERFORMED WITHIN SPECIFICATION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOVASCULAR TREATMENT (EVT) PROCEDURE THE CATHETER WAS SEPARATED. THE 90% STENOSED TARGET LESION WAS LOCATED AT THE MODERATELY TORTUOUS AND NON-CALCIFIED SUPERFICIAL FEMORAL ARTERY. AN F/G, ATLANTIS 018 40 MHZ IMAGING CATHETER WAS SELECTED TO IMAGE THE TARGET LESION. THE PHYSICIAN PERFORMED PRE INTRAVASCULAR ULTRASOUND (IVUS) PROCEDURE WITHOUT ANY ISSUE AND NO RESISTANCE WAS ENCOUNTERED. DURING POST-IVUS FOR FINAL CHECK AFTER STENT DEPLOYMENT, RESISTANCE WAS ENCOUNTERED WHEN THE PHYSICIAN ATTEMPTED TO RELOAD THE F/G, ATLANTIS 018 40 MHZ ON THE NON-BSC GUIDEWIRE AND THE TIP OF THE ATLANTIS IMAGING CATHETER WAS SEPARATED INTO 2 PIECES AT THE DISTAL RADIO OPAQUE (RO) MARKER. THIS EVENT OCCURRED OUTSIDE THE PATIENT. POST-IVUS WAS NOT PERFORMED DUE TO THIS EVENT AND PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOVASCULAR TREATMENT (EVT) PROCEDURE THE CATHETER WAS SEPARATED. THE 90% STENOSED TARGET LESION WAS LOCATED AT THE MODERATELY TORTUOUS AND NON-CALCIFIED SUPERFICIAL FEMORAL ARTERY. AN F/G, ATLANTIS 018 40MHZ IMAGING CATHETER WAS SELECTED TO IMAGE THE TARGET LESION. THE PHYSICIAN PERFORMED PRE INTRAVASCULAR ULTRASOUND (IVUS) PROCEDURE WITHOUT ANY ISSUE AND NO RESISTANCE WAS ENCOUNTERED. DURING POST-IVUS FOR FINAL CHECK AFTER STENT DEPLOYMENT, RESISTANCE WAS ENCOUNTERED WHEN THE PHYSICIAN ATTEMPTED TO RELOAD THE F/G, ATLANTIS 018 40MHZ ON THE NON-BSC GUIDEWIRE AND THE TIP OF THE ATLANTIS IMAGING CATHETER WAS SEPARATED INTO 2 PIECES AT THE DISTAL RADIO OPAQUE (RO) MARKER. THIS EVENT OCCURRED OUTSIDE THE PATIENT. POST-IVUS WAS NOT PERFORMED DUE TO THIS EVENT AND PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234572 ATLANTIS? 018 TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX BOSTON SCIENTIFIC - FREMONT (SUD) M001FG000240 15789289

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: 6F/TERUMO