BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS 018 PERIPHERAL IMAGING CATHETER

    MDR report key: 2141794 · Received June 27, 2011

    Report

    Report Number
    2134265-2011-02596
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 30, 2011
    Report Date
    May 30, 2011
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    ITX
    PMA / PMN Number
    K073623
    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 MANUFACTURER: EXAMINATION OF THE RETURNED DEVICE REVEALED THE DISTAL TIP END WAS BROKEN OFF AND MISSING APPROXIMATELY .5CM LONG FROM THE RO MARKER BAND WHEN RECEIVED. THE RETURNED CATHETER MEASURED 170.6CM LONG. THE BROKEN DISTAL TIP APPEARED STRETCHED. THERE WAS NO DAMAGE OBSERVED ON THE GUIDEWIRE EXIT PORT ASSEMBLY. A KINK WAS OBSERVED IN THE DISTAL SHEATH TIP ASSEMBLY AT 103.1CM FROM FEMORAL MARKER AT DISTAL SIDE. IMAGE CHARACTERIZATION TESTING REVEALED THAT NO IMAGE APPEARED IN THE SYSTEM DUE TO ELECTRICAL OPEN AT DISTAL WHICH IS NOT RELATED TO THE TIP DETACHMENT. NO MANUFACTURING DEFECTS WERE OBSERVED DURING VISUAL AND MICROSCOPIC INSPECTION OF THE TRANSDUCER, DISTAL HOUSING, OR DISTAL END OF THE DRIVE CABLE. NO OTHER ISSUES OR DEFECTS WERE OBSERVED DURING VISUAL OR FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. EXAMINATION OF THE FRACTURE SITE SHOWED STRETCHED AREAS, SUGGESTING THAT THE DEVICE WAS PULLED AGAINST RESISTANCE, RESULTING IN THE OBSERVED TIP SEPARATION. RESISTANCE BETWEEN THE CATHETER AND HEMOSTASIS VALVE OR PROCEDURAL/ANATOMICAL FACTORS LIMITING THE PERFORMANCE OF THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE TIP DETACHMENT. THE MOST PROBABLE ROOT CAUSE IS UNDETERMINABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE A TIP DETACHMENT OCCURRED. A RIGHT INGUINAL APPROACH WAS USED. A 6FR NON-BSC INTRODUCER SHEATH WAS INSERTED AND A NON-BSC 0.018 GUIDE WIRE WAS PLACED. THE 100% STENOSED LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS LEFT POPLITEAL ARTERY. THREE PULLBACKS WERE PERFORMED AND RESISTANCE WAS ENCOUNTERED BETWEEN THE CATHETER AND THE HEMOSTASIS VALVE DURING THE PROCEDURE. AS THE PHYSICIAN ATTEMPTED TO LOAD THE ATLANTIS PERIPHERAL IMAGING CATHETER ONTO THE 0.018 NON-BSC GUIDE WIRE TO PERFORM A FOURTH PULLBACK, SEVERAL CENTIMETERS OF THE ATLANTIS PERIPHERAL IMAGING CATHETER DISTAL TIP DETACHED OUTSIDE OF THE PATIENT. THE PHYSICIAN USED A STERLING ES BALLOON CATHETER TO DILATE THE LESION TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT COMPLICATIONS. THE PATIENT¿S STATUS POST PROCEDURE IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE A TIP DETACHMENT OCCURRED. A RIGHT INGUINAL APPROACH WAS USED. A 6FR NON-BSC INTRODUCER SHEATH WAS INSERTED AND A NON-BSC 0.018 GUIDE WIRE WAS PLACED. THE 100% STENOSED LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS LEFT POPLITEAL ARTERY. THREE PULLBACKS WERE PERFORMED AND RESISTANCE WAS ENCOUNTERED BETWEEN THE CATHETER AND THE HEMOSTASIS VALVE DURING THE PROCEDURE. AS THE PHYSICIAN ATTEMPTED TO LOAD THE ATLANTIS PERIPHERAL IMAGING CATHETER ONTO THE 0.018 NON-BSC GUIDE WIRE TO PERFORM A FOURTH PULLBACK, SEVERAL CENTIMETERS OF THE ATLANTIS PERIPHERAL IMAGING CATHETER DISTAL TIP DETACHED OUTSIDE OF THE PATIENT. THE PHYSICIAN USED A STERLING ES BALLOON CATHETER TO DILATE THE LESION TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT COMPLICATIONS. THE PATIENT'S STATUS POST PROCEDURE IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLANTIS 018 PERIPHERAL IMAGING CATHETER TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX BOSTON SCIENTIFIC - FREMONT M001FG000240 14090831

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDING INTRODUCER: 6FR PARENT| GUIDE WIRE: TREASURE 0.018