BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATINUM PLUS?

    MDR report key: 3121658 · Received May 21, 2013

    Report

    Report Number
    2134265-2013-03301
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K945379
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: VISUAL INSPECTION OF THE COMPLAINT DEVICE PRESENTED THE SPRING TIP WAS UNRAVELED. DEVICE PRESENTED THE DISTAL TIP DAMAGED, WITH THE SPRING TIP ELONGATED AND THE ABSENCE OF THE BALL WELD. ALL THE OUTER DIAMETER MEASUREMENTS ARE WITHIN THE SPECIFICATIONS. TWO SEGMENTS OF PLATINUM PLUS-PI (CORE WIRE AND SPRING TIP) WERE SENT TO (B)(4). THE ANALYSIS RESULTS SHOWED THE CORE WIRE PRESENTED EVIDENCE OF TORSION WITH BENDING AS CAUSE OF THE WIRE FAILURE AND THE SPRING TIP PRESENTED EVIDENCES OF SHEAR/TEAR TENSION AS THE CAUSE OF WIRE FAILURE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVISION TREATMENT PROCEDURE A GUIDE WIRE TIP DETACHMENT OCCURRED. A 0.018INCH X 180CM PLATINUM PLUS GUIDE WIRE UNRAVELED, THE TIP DETACHED AND REMAINED INSIDE THE RIGHT DORSAL PEDIS ARTERY OF THE PATIENTS¿ FOOT. THE DETACHED PORTION OF THE GUIDE WIRE WAS NOT ABLE TO BE RETRIEVED WITH A SNARE, THEREFORE, LEFT IN SITU. THE PROCEDURE WAS COMPLETED AND THE PHYSICIAN IS MONITORING THE MEDICAL SITUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVISION TREATMENT PROCEDURE A GUIDE WIRE TIP DETACHMENT OCCURRED. A 0.018INCH X 180CM PLATINUM PLUS GUIDE WIRE UNRAVELED, THE TIP DETACHED AND REMAINED INSIDE THE RIGHT DORSAL PEDIS ARTERY OF THE PATIENT'S FOOT. THE DETACHED PORTION OF THE GUIDE WIRE WAS NOT ABLE TO BE RETRIEVED WITH A SNARE, THEREFORE LEFT IN SITU. THE PROCEDURE WAS COMPLETED AND THE PHYSICIAN IS MONITORING THE MEDICAL SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224302 PLATINUM PLUS? WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) M001466040 14142627

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R