BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEGADE? STC 18

    MDR report key: 3955490 · Received July 24, 2014

    Report

    Report Number
    2134265-2014-04194
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    March 28, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    DQO
    PMA / PMN Number
    K023681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OLD AND ABOVE. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RECEIVED FOR EVALUATION. EVALUATION OF THE RETURNED DEVICE REVEALED A YELLOW DRY FOREIGN MATERIAL (FM) ON THE PROXIMAL END OF THE CATHETER AND UNDER THE STRAIN RELIEF. THE SOURCE OF THIS MATERIAL IS UNKNOWN AND THE TYPE OF FM CANNOT BE CONCLUSIVELY DETERMINED. THE DEVICE WAS FLUSHED WITH WATER USING A SYRINGE. NO BLOCKAGES OR LEAKS WERE PRESENT ON THE DEVICE. A MANDREL WAS ADVANCED THROUGH THE CATHETER. NO RESISTANCE OCCURRED DURING ADVANCEMENT OF THE MANDREL. A COATING CONFIRMATION TEST WAS PERFORMED WHICH REVEALED THE DAMAGE TO THE COATING PRESENT ON THE DEVICE. NO FLAKING OR PEELING OF THE COATING OCCURRED DURING THIS TEST. 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 PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR# 2134265-2014-02204. REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(4)2014. IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED WHEN MOVING THIS DEVICE. 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. HOWEVER, DEVICE ANALYSIS REVEALED A FOREIGN MATERIAL (FM)ON THE PROXIMAL END OF THE CATHETER AND UNDER THE STRAIN RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433753 RENEGADE? STC 18 CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - CORK M001181250 16380025

    Patients

    Seq Age Sex Outcome Treatment
    1 ATLANTIS 018| GUIDE WIRE: V-18| INTRODUCER SHEATH: SUPERSHEATH