BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING

    MDR report key: 2042641 · Received April 6, 2011

    Report

    Report Number
    2134265-2011-01004
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 5, 2011
    Report Date
    March 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K945379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: VISUAL AND MICROSCOPIC EVALUATION OF THE RETURNED DEVICE REVEALED THE GUIDE WIRE WAS RECEIVED WITH ITS ORIGINAL POUCH, LOADED INSIDE THE HOOP. DEVICE PRESENTS SPRING TIP DAMAGE. A KINK WAS NOTED 1.37CM APPROX. FROM THE DISTAL END. THE GUIDE WIRE WAS BENT AT 0.5CM APPROX. FROM THE DISTAL END. ALL THE OUTER DIAMETER MEASUREMENTS ARE WITHIN THE SPECIFICATIONS. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS INTERVENTIONAL (PCI) PROCEDURE THE GUIDE WIRE TIP BROKE. A PLATINUM PLUS-3 018/180 GUIDE WIRE HAD BEEN ADVANCED TO AN UNKNOWN LOCATION. DURING THE PROCEDURE, THE TIP OF THE GUIDE WIRE BROKE BUT DID NOT COMPLETELY DETACH FROM THE REMAINDER OF THE WIRE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS INTERVENTIONAL (PCI) PROCEDURE THE GUIDE WIRE TIP BROKE. A PLATINUM PLUS-3 018/180 GUIDE WIRE HAD BEEN ADVANCED TO AN UNKNOWN LOCATION. DURING THE PROCEDURE, THE TIP OF THE GUIDE WIRE BROKE BUT DID NOT COMPLETELY DETACH FROM THE REMAINDER OF THE WIRE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA M001466040 14027331

    Patients

    Seq Age Sex Outcome Treatment
    1