BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETIX PLUS PTCA GUIDEWIRE

    MDR report key: 1903440 · Received November 19, 2010

    Report

    Report Number
    2134265-2010-05155
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 27, 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
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A KINETIX PLUS GUIDEWIRE WITH A CORE WIRE FRACTURE LOCATED APPROXIMATELY 6.25IN DISTALLY FROM THE ADHESIVE PROXIMAL RAMP. THE HIGH TORQUE SLEEVE (HTS) WAS ALSO FRACTURED IN THE SAME LOCATION AS THE COREWIRE. MICROSCOPIC INSPECTION REVEALED THE COIL WIRE/CORE WIRE/RIBBON (CCR) JOINT AND THE DISTAL TIP WERE DETACHED/SEPARATED FROM THE GUIDEWIRE AND NOT RETURNED FOR PRODUCT ANALYSIS. THE DEVICE WAS SENT FOR ANALYSIS TO DETERMINE THE CAUSE OF THE COREWIRE FRACTURE, WHICH CONCLUDED THE FOLLOWING: THE NITINOL CORE WIRE AND HTS FRACTURED DUE TO DUCTILE OVERLOAD CAUSED BY BENDING. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS INTERVENTION (PCI) PROCEDURE THE TIP OF THE GUIDE WIRE BROKE. A KINETIX PLUS, STR, 185CM GUIDE WIRE HAD BEEN ADVANCED TO AN UNSPECIFIED LOCATION WHEN IT WAS NOTICED THAT THE WIRE "LOOPED ITSELF". DURING ATTEMPTS TO STRAIGHTEN THE WIRE, APPROXIMATELY 2CM OF THE TIP OF THE WIRE DETACHED INSIDE OF THE PATIENT. ATTEMPTS TO RETRIEVE THE WIRE TIP WERE UNSUCCESSFUL. THE DETACHED TIP WAS JAILED AGAINST THE VESSEL WALL WITH THE IMPLANT OF AN UNKNOWN STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME GUIDE WIRE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS INTERVENTION (PCI) PROCEDURE THE TIP OF THE GUIDE WIRE BROKE. A KINETIX PLUS, STR, 185CM GUIDE WIRE HAD BEEN ADVANCED TO AN UNSPECIFIED LOCATION WHEN IT WAS NOTICED THAT THE WIRE "LOOPED ITSELF". DURING ATTEMPTS TO STRAIGHTEN THE WIRE, APPROXIMATELY 2CM OF THE TIP OF THE WIRE DETACHED INSIDE OF THE PATIENT. ATTEMPTS TO RETRIEVE THE WIRE TIP WERE UNSUCCESSFUL. THE DETACHED TIP WAS JAILED AGAINST THE VESSEL WALL WITH THE IMPLANT OF AN UNKNOWN STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME GUIDE WIRE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS INTERVENTION (PCI) PROCEDURE THE TIP OF THE GUIDE WIRE BROKE. A KINETIX PLUS, STR, 185CM GUIDE WIRE HAD BEEN ADVANCED TO AN UNSPECIFIED LOCATION WHEN IT WAS NOTICED THAT THE WIRE "LOOPED ITSELF". DURING ATTEMPTS TO STRAIGHTEN THE WIRE, APPROXIMATELY 2CM OF THE TIP OF THE WIRE DETACHED INSIDE OF THE PATIENT. ATTEMPTS TO RETRIEVE THE WIRE TIP WERE UNSUCCESSFUL. THE DETACHED TIP WAS JAILED AGAINST THE VESSEL WALL WITH THE IMPLANT OF AN UNKNOWN STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME GUIDE WIRE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETIX PLUS PTCA GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE H74939122030

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention