BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT²¿

    MDR report key: 2823053 · Received November 7, 2012

    Report

    Report Number
    2134265-2012-06650
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 9, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K030617
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RECEIVED AND VISUAL INSPECTION NOTED THE DISTAL TIP WAS FRACTURED AT 183.1 CM FROM THE PROXIMAL END. DIMENSIONAL INSPECTION WAS PERFORMED AND THE DEVICE MEETS SPECIFICATIONS. THE DEVICE WAS SENT FOR EXTERNAL ANALYSIS TO DETERMINE THE FRACTURE FAILURE MODE. THE LAB RETURNED THE FOLLOWING RESULTS: FAILURE OCCURRED DUE TO A 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A TIP SEPARATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON CALCIFIED DE NOVO PROXIMAL RIGHT CORONARY ARTERY (RCA). THE 185CM PT2 MODERATE SUPPORT GUIDE WIRE WAS ADVANCED PAST THE LESION AND AS TURNING, APPROXIMATELY 1 1/2 CENTIMETER OF THE TIP BROKE OFF. THE TIP WAS NOT RETRIEVED AND A NEW GUIDE WIRE WAS USED WITH AN UNSPECIFIED 2.25 X 8 MM BARE METAL STENT TO SUCCESSFULLY JAIL THE TIP IN THE RCA. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A TIP SEPARATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON CALCIFIED DE NOVO PROXIMAL RIGHT CORONARY ARTERY (RCA). THE 185CM PT2 MODERATE SUPPORT GUIDE WIRE WAS ADVANCED PAST THE LESION AND AS TURNING, APPROXIMATELY 1 1/2 CENTIMETER OF THE TIP BROKE OFF. THE TIP WAS NOT RETRIEVED AND A NEW GUIDE WIRE WAS USED WITH AN UNSPECIFIED 2.25 X 8 MM BARE METAL STENT TO SUCCESSFULLY JAIL THE TIP IN THE RCA. 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 PT²¿ WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) H7493893103J0 15319434

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention