BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS? 018

    MDR report key: 3770588 · Received April 24, 2014

    Report

    Report Number
    2134265-2014-02204
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 28, 2014
    Report Date
    March 31, 2014
    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

    DEVICE RETURNED TO MFR: THE DEVICE WAS RETURNED FOR EVALUATION. EXAMINATION OF THE RETURNED DEVICE REVEALED A BROKEN AND MISSING DISTAL TIP. APPROXIMATELY 5 MM DISTAL TIP WAS MISSING. THE BROKEN DISTAL TIP SECTION APPEARED STRETCHED AND NECKDOWN AT THE RO MARKER AREA. A KINK WAS OBSERVED ON THE RETURNED GUIDEWIRE AT 2.8 CM FROM THE GUIDEWIRE TIP END. DURING ANALYSIS, THE RETURNED NON BSC GUIDEWIRE (0.018") WAS INSERTED INTO THE GUIDEWIRE EXIT PORT. IT DID NOT THREAD ALL THE WAY THROUGH. A TEST GUIDEWIRE (0.014") WAS INSERTED AND CANNOT GO THROUGH THE EXIT PORT DUE TO BROKEN DISTAL TIP. DURING IMAGE CHARACTERIZATION TESTING IN THE ROLLER COASTER MODEL, A GOOD SQUARE IMAGE APPEARED IN THE SYSTEM AND THE PRODUCT PERFORMED WITHIN SPECIFICATION. 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 WAS UNABLE TO BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OLD AND ABOVE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISTAL TIP OF THIS DEVICE WAS DETACHED. THE 80% STENOSED TARGET LESION WAS LOCATED AT THE MILDLY TORTUOUS AND MILDLY CALCIFIED RIGHT EXTERNAL ILIAC ARTERY. THE VASCULAR ACCESS WAS OBTAINED FROM THE SIDE OF THE LESION WITH RETROGRADE APPROACH. DURING THE DILATATION OF THE LOWER LIMB VESSEL, V-18 CONTROL WIRE GUIDE WIRE WAS ABLE TO CROSS THE LESION, THEN INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED USING AN ATLANTIS 018 IMAGING CATHETER. STENT SIZING WAS DONE DURING IVUS. WHILE REMOVING THE IMAGING CATHETER TO PERFORM STENTING, RESISTANCE WAS ENCOUNTERED NEAR A HEMOSTASIS VALVE OF THE SHEATH. THE DISTAL TIP OF THE IMAGING CATHETER SEEMED TO COME INTO CONTACT WITH THE VALVE. THE DEVICE WAS REMOVED BY FLUSHING IT. HOWEVER, THE DISTAL TIP WAS NOTICED TO BE DETACHED. THE DETACHED PART WAS CAUGHT ON A PORTION OF THE GUIDE WIRE OUTSIDE THE PATIENT'S BODY. THEY COULD NOT DETERMINE IF THE DETACHED PART WAS STRETCHED OR NOT. NO FRAGMENT WAS FOUND IN THE BODY. THE PHYSICIAN THOUGHT THAT THE DETACHMENT OCCURRED OUTSIDE THE PATIENT'S BODY. A RENEGADE MICRO CATHETER WAS ALSO USED DURING THE PROCEDURE AND RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE GUIDE WIRE THROUGH IT. THE PHYSICIAN ALLEGED THAT RESISTANCE WAS ALSO ENCOUNTERED BETWEEN THE MICRO CATHETER AND THE IMAGING CATHETER AND BETWEEN THE GUIDE WIRE AND THE IMAGING CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME IMAGING CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISTAL TIP OF THIS DEVICE WAS DETACHED. THE 80% STENOSED TARGET LESION WAS LOCATED AT THE MILDLY TORTUOUS AND MILDLY CALCIFIED RIGHT EXTERNAL ILIAC ARTERY. THE VASCULAR ACCESS WAS OBTAINED FROM THE SIDE OF THE LESION WITH RETROGRADE APPROACH. DURING THE DILATATION OF THE LOWER LIMB VESSEL, V-18¿ CONTROL WIRE¿ GUIDE WIRE WAS ABLE TO CROSS THE LESION, THEN INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED USING AN ATLANTIS¿ 018 IMAGING CATHETER. STENT SIZING WAS DONE DURING IVUS. WHILE REMOVING THE IMAGING CATHETER TO PERFORM STENTING, RESISTANCE WAS ENCOUNTERED NEAR A HEMOSTASIS VALVE OF THE SHEATH. THE DISTAL TIP OF THE IMAGING CATHETER SEEMED TO COME INTO CONTACT WITH THE VALVE. THE DEVICE WAS REMOVED BY FLUSHING IT. HOWEVER, THE DISTAL TIP WAS NOTICED TO BE DETACHED. THE DETACHED PART WAS CAUGHT ON A PORTION OF THE GUIDE WIRE OUTSIDE THE PATIENT'S BODY. THEY COULD NOT DETERMINE IF THE DETACHED PART WAS STRETCHED OR NOT. NO FRAGMENT WAS FOUND IN THE BODY. THE PHYSICIAN THOUGHT THAT THE DETACHMENT OCCURRED OUTSIDE THE PATIENT'S BODY. A RENEGADE MICRO CATHETER WAS ALSO USED DURING THE PROCEDURE AND RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE GUIDE WIRE THROUGH IT. THE PHYSICIAN ALLEGED THAT RESISTANCE WAS ALSO ENCOUNTERED BETWEEN THE MICRO CATHETER AND THE IMAGING CATHETER AND BETWEEN THE GUIDE WIRE AND THE IMAGING CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME IMAGING CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249680 ATLANTIS? 018 TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX BOSTON SCIENTIFIC - FREMONT (SUD) M001FG000240 16564012

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: SUPERSHEATH| MICRO CATHETER: RENEGADE| BALLOON CATHETER: STERLING (FOR PRE DILATATION)| STENT: EPIC| INFLATION DEVICE: EVEREST| GUIDE WIRE: V-18