BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETIX PTCA GUIDEWIRE

    MDR report key: 1842547 · Received September 23, 2010

    Report

    Report Number
    2134265-2010-04307
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 31, 2010
    Report Date
    August 31, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K081021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR, EVAL SUMMARY ATTACHED, METHOD CODES, RESULT CODES, CONCLUSION CODES: UPDATED DEVICE EVALUATED BY MFR: UPON INITIAL RECEIPT OF THE RETURNED DEVICE, THE DISTAL TIP FROM THE PROXIMAL END OF THE COIL WIRE/CORE WIRE/RIBBON JOINT (CCR) WERE NOT RETURNED FOR ANALYSIS. THE RETURNED HIGH TORQUE SLEEVE (HTS) MEASURED APPROXIMATELY 6.5 IN. MICROSCOPIC INSPECTION REVEALED THAT THE CORE WIRE WAS STICKING OUT OF THE STRETCHED AREA OF THE HTS. THE STRETCHED PORTION OF THE HTS WAS CUT BACK TO REVEAL THE CORE WIRE. THE CORE WIRE WAS BROKEN. ANALYTICAL TESTING CONCLUDED THE FOLLOWING: THE MAJOR PORTION OF THE FRACTURE SURFACE ON THE NITINOL CORE WIRE SHOWED EVIDENCE OF CORROSION (PITTING WITH CORROSION RESIDUE). A MINOR PORTION OF THE FRACTURE SURFACE SHOWED EVIDENCE OF DUCTILE OVERLOAD WHICH IS LIKELY THE LAST AREA TO FRACTURE. ENERGY DISPERSIVE SPECTROSCOPY (EDS) DETECTED FOREIGN ELEMENTS IN THE RESIDUE ON THE FRACTURE SURFACE WHICH CONTAINED CARBON, OXYGEN, SILICON AND SULFUR. EDS DETECTED FOREIGN ELEMENTS IN THE RESIDUE ON THE SIDE OF THE WIRE NEAR THE FRACTURE WHICH CONTAINED CARBON, OXYGEN, SODIUM, PHOSPHOROUS, SULFUR, CHLORINE AND SILICON. EDS ALSO DETECTED TIN AND SILVER FROM THE SOLDER IN THIS AREA. 4) EDS DETECTED FOREIGN ELEMENTS IN THE PITS ON THE SIDE OF THE WIRE NEAR THE FRACTURE WHICH INCLUDED CARBON, OXYGEN, SODIUM, SILICON, SULFUR AND CHLORINE. TIN WAS DETECTED FROM THE SOLDER. 5) EDS IS NOT CAPABLE OF IDENTIFYING CHEMICAL COMPOUNDS AND IT CANNOT BE DETERMINED WHAT THE CHEMICAL COMPOUND WAS THAT CAUSED THE CORROSION. SINCE THE FRACTURE OCCURRED IN THE AREA WHERE SOLDER WAS PRESENT, IT IS POSSIBLE THAT PHOSPHORIC ACID FROM THE SOLDER FLUX MAY BE THE CAUSE OF THE CORROSION. 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).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE GUIDE WIRE REMOVAL DIFFICULTY WAS ENCOUNTERED. THE KINETIX GUIDE WIRE WAS ADVANCED THROUGH A LEFT ANTERIOR DESCENDING ARTERY (LAD) STENT INTO THE DIAGONAL BRANCH UNTIL THE GUIDE WIRE WOULD NOT PROCEED ANY FURTHER AND THE WIRE WAS UNABLE TO MOVE FREELY. THE PHYSICIAN ATTEMPTED TO REMOVE THE GUIDE WIRE AND EXPERIENCED RESISTANCE AND A 'POP' AS THE WIRE BECAME FREE. THE WIRE WAS REMOVED FROM THE PATIENT AND UPON EXAMINATION IT WAS NOTICED THAT THE CORE WIRE SEEMED TO BE PROTRUDING FROM THE NITINOL SLEEVE A SHORT DISTANCE FROM THE TIP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS STABLE. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE GUIDE WIRE REMOVAL DIFFICULTY WAS ENCOUNTERED. THE KINETIX GUIDE WIRE WAS ADVANCED THROUGH A LEFT ANTERIOR DESCENDING ARTERY (LAD) STENT INTO THE DIAGONAL BRANCH UNTIL THE GUIDE WIRE WOULD NOT PROCEED ANY FURTHER AND THE WIRE WAS UNABLE TO MOVE FREELY. THE PHYSICIAN ATTEMPTED TO REMOVE THE GUIDE WIRE AND EXPERIENCED RESISTANCE AND A 'POP' AS THE WIRE BECAME FREE. THE WIRE WAS REMOVED FROM THE PATIENT AND UPON EXAMINATION IT WAS NOTICED THAT THE CORE WIRE SEEMED TO BE PROTRUDING FROM THE NITINOL SLEEVE A SHORT DISTANCE FROM THE TIP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS STABLE. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETIX PTCA GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE H7493912201J2 13451655

    Patients

    Seq Age Sex Outcome Treatment
    1