BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETIX PTCA GUIDEWIRE

    MDR report key: 2042650 · Received April 6, 2011

    Report

    Report Number
    2134265-2011-01035
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K081021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RECEIVED AT THE COMPLAINT INVESTIGATION SITE FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY TREATMENT PROCEDURE A GUIDE WIRE FRACTURE OCCURRED. THE LESION WAS LOCATED AT THE CIRCUMFLEX (CX) AND OBTUSE MARGINAL (OM) BIFURCATION. THE 185CM KINETIX GUIDE WIRE WAS ADVANCED INTO THE CX AND A STENT WAS DEPLOYED ACROSS THE CX. THE KINETIX GUIDE WIRE WAS REMOVED AND THEN ADVANCED THROUGH THE STENT STRUTS OF THE PREVIOUSLY IMPLANTED STENT IN THE CX AND INTO THE OM. NEXT, A BALLOON CATHETER WAS ADVANCED OVER THE KINETIX GUIDE WIRE AND THROUGH THE STRUTS OF THE STENT IN THE CX. THE BALLOON WAS INFLATED TO CREATE AN OPENING IN THE STENT STRUTS SO THAT ANOTHER STENT COULD BE ADVANCED THROUGH THE STENT STRUTS AND INTO THE OM. THE PHYSICIAN ATTEMPTED TO ADVANCE THIS STENT THROUGH THE OPENING IN THE CX STENT STRUTS, HOWEVER, THIS ATTEMPT WAS UNSUCCESSFUL. THE PHYSICIAN PULLED BACK ON THE STENT DELIVERY SYSTEM AND ADVANCED A SECOND KINETIX GUIDE WIRE TO SERVE AS THE BUDDY WIRE. THE PHYSICIAN RE-ATTEMPTED TO ADVANCE THE STENT THROUGH THE OPENING IN THE STENT STRUTS OF THE STENT IMPLANTED IN THE CX, HOWEVER, THIS ATTEMPT WAS UNSUCCESSFUL. NEXT, THE PHYSICIAN DECIDED TO REMOVE THE KINETIX BUDDY GUIDE WIRE, HOWEVER, THE KINETIX BUDDY WIRE WAS STUCK. THE PHYSICIAN PULLED THE KINETIX BUDDY WIRE SEVERAL TIMES, HOWEVER, THE DISTAL TIP OF THE KINETIX WIRE DETACHED IN THE OM. FLUOROSCOPY WAS USED TO LOCATE THE DETACHED KINETIX GUIDE TIP WHICH HAD MIGRATED INTO THE DISTAL PORTION OF THE OM. THE PHYSICIAN SUCCESSFULLY SNARED THE DETACHED KINETIX GUIDE WIRE TIP TO COMPLETE THE PROCEDURE. THE PHYSICIAN DID NOT ATTEMPT TO ADVANCE AND PLACE ANOTHER STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETIX PTCA GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE H74939122010

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDE WIRE: KINETIX