BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUGE GUIDE WIRE

    MDR report key: 1803210 · Received August 17, 2010

    Report

    Report Number
    2134265-2010-03873
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 20, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    DQX
    PMA / PMN Number
    K973945
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE RETURNED DEVICE WAS RECEIVED IN TWO PIECES. THE FRACTURE WAS LOCATED 32CM FROM THE PROXIMAL END. THE OUTSIDE DIAMETER (OD) OF THE WIRE WAS MEASURED WITH A MICROMETER AT THREE LOCATIONS AND WAS FOUND TO BE WITHIN SPECIFICATIONS. SEM ANALYSIS OF BOTH FRACTURE SITES REVEALED THAT THE HYPOTUBE FRACTURE SITE EXHIBITED EVIDENCE OF COMPRESSION AND TENSION. THE FRACTURE SURFACE EXHIBITED ELONGATED DIMPLE RUPTURES. THE INNER CORE WIRE EXHIBITED MATERIAL ELONGATION ALONG WITH EQUIAXED DIMPLE RUPTURES TYPICAL OF MATERIAL IN TENSION. NO MATERIAL ANOMALIES WERE NOTED. 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, A GUIDE WIRE FRACTURE OCCURRED. THE LESION LOCATION AND CHARACTERISTICS ARE UNKNOWN. THE 182CM LUGE GUIDE WIRE WAS ADVANCED ACROSS THE LESION. THE PHYSICIAN USED A TORQUE DEVICE TO POSITION THE WIRE IN PREPARATION TO ADVANCE EITHER A BALLOON CATHETER OR A STENT. WHEN THE PHYSICIAN REMOVED THE TORQUE DEVICE, THE PROXIMAL 10CM OF THE LUGE WIRE DETACHED OUTSIDE OF THE PATIENT. ANOTHER LUGE WIRE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A GUIDE WIRE FRACTURE OCCURRED. THE LESION LOCATION AND CHARACTERISTICS ARE UNKNOWN. THE 182CM LUGE GUIDE WIRE WAS ADVANCED ACROSS THE LESION. THE PHYSICIAN USED A TORQUE DEVICE TO POSITION THE WIRE IN PREPARATION TO ADVANCE EITHER A BALLOON CATHETER OR A STENT. WHEN THE PHYSICIAN REMOVED THE TORQUE DEVICE, THE PROXIMAL 10CM OF THE LUGE WIRE DETACHED OUTSIDE OF THE PATIENT. ANOTHER LUGE WIRE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUGE GUIDE WIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MIAMI H7491213001J0

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR