BEUDAMED
    FDA Adverse Event Death Summary report: N

    KINETIX PLUS PTCA GUIDEWIRE

    MDR report key: 1894960 · Received November 10, 2010

    Report

    Report Number
    2134265-2010-04805
    Event Type
    Death
    Date Received
    November 10, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 12, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K081021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) RELATES TO COMPONENT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE GUIDEWIRE WAS RETURNED FRACTURED APPROXIMATELY 7.25IN FROM THE PROXIMAL EDGE OF THE INCONEL CONNECTOR, ONLY THE PROXIMAL PORTION OF THE WIRE WAS RETURNED. THE DISTAL END (ALL COMPONENTS DISTAL TO THE FRACTURE INCLUDING THE HIGH TORQUE SLEEVE (HTS) AND THE DISTAL TIP) WERE NOT RETURNED FOR ANALYSIS. MICROSCOPIC INSPECTION REVEALED THE FRACTURE SURFACE OF THE CORE WIRE HAD A BITE MARK, CHUNK OF MATERIAL BROKEN OFF WHICH WAS MOST LIKELY CAUSED BY THE BENDING OF THE GUIDEWIRE. THE DEVICE WAS SENT FOR SCANNING ELECTRON MICROSCOPE (SEM) ANALYSIS TO CONFIRM THE SUGGESTED CORE WIRE FRACTURE AND THE FOLLOWING RESULTS WERE OBTAINED: THE NITINOL CORE WIRE SHOWED EVIDENCE THAT THE FRACTURE OCCURRED BY BENDING. THE WIRE WAS BENT IN THE AREA WHERE THE FRACTURE OCCURRED. AN ELONGATED DIMPLE STRUCTURE WAS PRESENT ON THE FRACTURE SURFACE WHICH IS REPRESENTATIVE OF DUCTILE OVERLOAD CAUSED BY BENDING. CRACKS OR FRACTURES WERE PRESENT PERPENDICULAR TO THE MAJOR FRACTURE SURFACE WHICH OFTEN OCCURS BY BENDING. THE SAME FEATURE WAS PRESENT ON A NITINOL CORE WIRE THAT WAS BENT TIGHTLY INTO A LOOP AND PULLED TO FAILURE. 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 # 2134265-2010-04797. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A TIP DETACHMENT OCCURRED AND POST PROCEDURE, THE PATIENT DIED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED CIRCUMFLEX ARTERY (CX). A KINETIX PLUS GUIDEWIRE WAS ADVANCED TO THE LESION AND THEN A NON BSC BALLOON WAS ADVANCED OVER THE WIRE FOR PREDILATION. WHILE TRYING TO REMOVE THE BALLOON CATHETER AFTER INFLATION, THE PHYSICIAN EXPERIENCED DIFFICULTY WITHDRAWING THE BALLOON CATHETER PAST A "CERTAIN PART" OF THE WIRE. THE GUIDEWIRE AND BALLOON CATHETER WERE REMOVED TOGETHER AS A SYSTEM AND AFTER THEY WERE REMOVED FROM THE PATIENT, THEY WERE ABLE TO BE SEPARATED. ONCE OUTSIDE THE PATIENT, A BREAK OCCURRED ON THE GUIDEWIRE WHERE THE SEVEN INCH NITINOL SLEEVE IS SOLDERED TO THE CORE WIRE. A SECOND KINETIX PLUS GUIDEWIRE WAS ADVANCED TO THE LESION ALONG WITH A BUDDY WIRE. AFTER AN UNSPECIFIED STENT WAS SUCCESSFULLY DEPLOYED, THE PHYSICIAN REMOVED THE BUDDY WIRE AND KINETIX GUIDEWIRE AND IT WAS NOTED THAT SIX OR SEVEN INCHES OF THE KINETIX GUIDEWIRE TIP REMAINED INSIDE OF THE VESSEL. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY SNARE THE REMAINING GUIDEWIRE TIP; HOWEVER, IT WAS NOTED THAT THE PATIENT EXPERIENCED ST ELEVATIONS DURING SNARING THAT WERE RESOLVED ONCE THE DETACHED TIP WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED AT THIS TIME WITH NO ADDITIONAL PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT "A COUPLE" OF DAYS LATER THE PATIENT PASSED AWAY DUE TO UNKNOWN CAUSES. THE PHYSICIAN DOES NOT ASSOCIATE THE PATIENT'S DEATH TO THE WIRE BREAKAGE.

    Description of Event or Problem · 1

    SAME CASE AS MFR # 2134265-2010-04797. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A TIP DETACHMENT OCCURRED AND POST PROCEDURE THE PATIENT DIED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED CIRCUMFLEX ARTERY (CX). A KINETIX PLUS GUIDEWIRE WAS ADVANCED TO THE LESION AND THEN A NON BSC BALLOON WAS ADVANCED OVER THE WIRE FOR PREDILATION. WHILE TRYING TO REMOVE THE BALLOON CATHETER AFTER INFLATION, THE PHYSICIAN EXPERIENCED DIFFICULTY WITHDRAWING THE BALLOON CATHETER PAST A 'CERTAIN PART' OF THE WIRE. THE GUIDEWIRE AND BALLOON CATHETER WERE REMOVED TOGETHER AS A SYSTEM AND AFTER THEY WERE REMOVED FROM THE PATIENT THEY WERE ABLE TO BE SEPARATED. ONCE OUTSIDE THE PATIENT A BREAK OCCURRED ON THE GUIDEWIRE WHERE THE SEVEN INCH NITINOL SLEEVE IS SOLDERED TO THE CORE WIRE. A SECOND KINETIX PLUS GUIDEWIRE WAS ADVANCED TO THE LESION ALONG WITH A BUDDY WIRE. AFTER AN UNSPECIFIED STENT WAS SUCCESSFULLY DEPLOYED, THE PHYSICIAN REMOVED THE BUDDY WIRE AND KINETIX GUIDEWIRE AND IT WAS NOTED THAT SIX OR SEVEN INCHES OF THE KINETIX GUIDEWIRE TIP REMAINED INSIDE OF THE VESSEL. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY SNARE THE REMAINING GUIDEWIRE TIP; HOWEVER, IT WAS NOTED THAT THE PATIENT EXPERIENCED ST ELEVATIONS DURING SNARING THAT WERE RESOLVED ONCE THE DETACHED TIP WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED AT THIS TIME WITH NO ADDITIONAL PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT "A COUPLE" OF DAYS LATER THE PATIENT PASSED AWAY DUE TO UNKNOWN CAUSES. THE PHYSICIAN DOES NOT ASSOCIATE THE PATIENT DEATH TO THE WIRE BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETIX PLUS PTCA GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE H7493912203J0

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death ANGIOSCULPT BALLOON CATHETER| KINETIX PLUS GUIDEWIRE