BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETIX PTCA GUIDEWIRE

    MDR report key: 1982225 · Received February 9, 2011

    Report

    Report Number
    2134265-2011-00250
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS FRACTURED. A PORTION OF THE HIGH TORQUE SLEEVE (HTS) MEASURING 1.5CM WAS RECEIVED SEPARATED FROM THE GUIDE WIRE WITH 5.5IN OF THE HTS REMAINING INTACT. MICROSCOPIC INSPECTION REVEALED THE COREWIRE WAS FRACTURED. THE DISTAL TIP INCLUDING THE COIL, COREWIRE, AND RIBBON (CCR JOINT) WERE DETACHED AND NOT RETURNED FOR ANALYSIS. ANALYTICAL TESTING CONCLUDED THAT THE CORE WIRE FRACTURE WAS CAUSED BY DUCTILE OVERLOAD CAUSED BY TENSILE OR BENDING FORCES. THE APPEARANCE OF THE FRACTURE SURFACE IS SUSPECTED TO BE DUE TO RUBBING AGAINST THE HTS OR THE MATING PORTION OF THE FRACTURE. 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

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY TREATMENT PROCEDURE, A GUIDE WIRE TIP DETACHMENT OCCURRED. THIS 185CM KINETIX GUIDE WIRE WAS ADVANCED AND DURING TORQUING THE WIRE WENT INTO A SMALL SIDE BRANCH. PRIOR TO ADVANCING A BALLOON CATHETER OVER THE WIRE, THE PHYSICIAN PULLED BACK ON THE GUIDE WIRE. AS THE WIRE WAS PULLED BACK, THE TIP OF THE WIRE DETACHED. THE TIP REMAINS INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY TREATMENT PROCEDURE, A GUIDE WIRE TIP DETACHMENT OCCURRED. THIS 185CM KINETIX GUIDE WIRE WAS ADVANCED AND DURING TORQUING THE WIRE WENT INTO A SMALL SIDE BRANCH. PRIOR TO ADVANCING A BALLOON CATHETER OVER THE WIRE, THE PHYSICIAN PULLED BACK ON THE GUIDE WIRE. AS THE WIRE WAS PULLED BACK, THE TIP OF THE WIRE DETACHED. THE TIP REMAINS INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    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 Other