BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT2 GUIDE WIRE

    MDR report key: 2010989 · Received March 8, 2011

    Report

    Report Number
    2134265-2011-00706
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 8, 2011
    Report Date
    April 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K030617
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: ONE DEVICE WAS RECEIVED IN A GENERIC PLASTIC BAG. ALL DEVICE OD MEASUREMENTS ARE WITHIN THE SPECIFICATION. VISUAL AND MICROSCOPIC ANALYSIS REVEALED THE DEVICE RETURNED WITH A FRACTURE AT 183.5 CM FROM THE PROXIMAL END. SEM ANALYSIS REVEALED THAT THE FRACTURED OCCURRED DUE TO TENSION OVERLOAD. 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN ARTERY. A 185CM PT2 MODERATE SUPPORT GUIDE WIRE WAS SELECTED AND DURING USE THE TIP OF THE GUIDE WIRE DETACHED AND REMAINED INSIDE THE PATIENT. THERE WAS NO ATTEMPT TO RETRIEVE THE DETACHED TIP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN ARTERY. A 185CM PT2 MODERATE SUPPORT GUIDE WIRE WAS SELECTED AND DURING USE THE TIP OF THE GUIDE WIRE DETACHED AND REMAINED INSIDE THE PATIENT. THERE WAS NO ATTEMPT TO RETRIEVE THE DETACHED TIP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PT2 GUIDE WIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA H74938931030

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other