BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT 2 (TM)

    MDR report key: 2231752 · Received September 1, 2011

    Report

    Report Number
    2134265-2011-03681
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 9, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS AND VISUAL INSPECTION OF THE RETURNED DEVICE FOUND A KINK AT 105.5CM FROM THE PROXIMAL END AND A FRACTURE LOCATED AT 183.3CM FROM THE PROXIMAL END. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A GUIDE WIRE TIP DETACHMENT OCCURRED. THE SEVERELY CALCIFIED LESION WAS LOCATED BELOW THE PATIENT'S KNEE. AT AN UNSPECIFIED TIME, THE 185CM PT2 MODERATE SUPPORT GUIDE WIRE WAS BEING RETRACTED INTO ANOTHER MANUFACTURERS' SUPPORT CATHETER WHEN THE RADIOPAQUE TIP BROKE OFF WITH NO NOTICEABLE SIGNIFICANT FRICTION AND WITHOUT APPLYING EXCESSIVE FORCE. THE DETACHED TIP WAS SUCCESSFULLY RETRIEVED USING A WIRE CUTTER AND NO WIRE SEGMENT REMAINED IN THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A GUIDE WIRE TIP DETACHMENT OCCURRED. THE SEVERELY CALCIFIED LESION WAS LOCATED BELOW THE PATIENT'S KNEE. AT AN UNSPECIFIED TIME, THE 185CM PT2 MODERATE SUPPORT GUIDE WIRE WAS BEING RETRACTED INTO ANOTHER MANUFACTURERS' SUPPORT CATHETER WHEN THE RADIOPAQUE TIP BROKE OFF WITH NO NOTICEABLE SIGNIFICANT FRICTION AND WITHOUT APPLYING EXCESSIVE FORCE. THE DETACHED TIP WAS SUCCESSFULLY RETRIEVED USING A WIRE CUTTER AND NO WIRE SEGMENT REMAINED IN THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PT 2 (TM) WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA H74938931030

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention QUICK CROSS EXTREME CATHETER