BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT²¿

    MDR report key: 2982341 · Received February 28, 2013

    Report

    Report Number
    2134265-2013-01002
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 31, 2013
    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
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: VISUAL INSPECTION WAS PERFORMED AND THE DEVICE WAS RETURNED IN TWO SECTIONS. THE DISTAL PORTION OF THE DEVICE PRESENTED A KINK AT 0.6CM FROM THE PROXIMAL END. DIMENSIONAL INSPECTION WAS PERFORMED AND ALL MEASUREMENTS WERE FOUND TO BE WITHIN SPECIFICATIONS. THE RETURNED DEVICE WAS SENT FOR EXTERNAL LAB ANALYSIS TO DETERMINE THE FRACTURE FAILURE MODE. THE EXTERNAL LAB RETURNED THE FOLLOWING RESULTS; FAILURE OCCURRED DUE TO A FATIGUE IN A BENDING MOMENT FOLLOWED BY A RAPID TENSION OVERLOAD. BOTH SECTIONS PRESENTED SAME FAILURE MODE. 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 PROCEDURE A TIP DETACHMENT OCCURRED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE RIGHT ATRIUM. A 185CM PT² GUIDE WIRE WAS ADVANCED TO THE RIGHT ATRIUM. APPROXIMATELY 20 TO 30 CM OF THE GUIDE WIRE TIP DETACHED. THE DETACHED PORTION WAS RETRIEVED APPROXIMATELY 2 HOURS AND 30 MINUTES LATER USING A NON-BSC GUIDE CATHETER AND SNARE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE A TIP DETACHMENT OCCURRED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE RIGHT ATRIUM. A 185CM PT² GUIDE WIRE WAS ADVANCED TO THE RIGHT ATRIUM. APPROXIMATELY 20 TO 30 CM OF THE GUIDE WIRE TIP DETACHED. THE DETACHED PORTION WAS RETRIEVED APPROXIMATELY 2 HOURS AND 30 MINUTES LATER USING A NON-BSC GUIDE CATHETER AND SNARE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86641 PT²¿ WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) H74938931030

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention