BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PT²?

    MDR report key: 3053490 · Received April 11, 2013

    Report

    Report Number
    2134265-2013-02815
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 10, 2013
    Report Date
    March 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K030617
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE PT2 GUIDE WIRE WAS RECEIVED IN A GENERIC PLASTIC BAG. AFTER VISUAL INSPECTION BEFORE DECONTAMINATION PROCESS, DEVICE WAS FOUND INSIDE A CATHETER. THE VISUAL INSPECTION WAS PERFORMED AND THE WIRE IS STUCK IN THE LATERAL HOLE OF THE CATHETER, THE DISTAL TIP IS DAMAGED AND PEELED AT 292.7CM APPROX. FROM THE PROXIMAL END TO DISTAL END. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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, GUIDE WIRE REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A NON BSC GUIDE CATHETER WAS ADVANCED TO THE LESION FOLLOWED BY A 300CM PT2 GUIDE WIRE. AS THEY WERE ADVANCING THE GUIDE WIRE, THE GUIDE WIRE WENT OUT ONE OF THE SIDEHOLES OF THE GUIDE CATHETER. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE GUIDE WIRE, THERE WAS A KNOT OUTSIDE OF THE GUIDE CATHETER AND THE PHYSICIAN WAS UNABLE TO REMOVE THE GUIDE WIRE. THE GUIDE CATHETER AND GUIDE WIRE WERE REMOVED AS ONE WITHOUT INCIDENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, GUIDE WIRE REMOVAL DIFFICULTIES WERE ENCOUNTERED.. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A NON BSC GUIDE CATHETER WAS ADVANCED TO THE LESION FOLLOWED BY A 300CM PT2 GUIDE WIRE. AS THEY WERE ADVANCING THE GUIDE WIRE, THE GUIDE WIRE WENT OUT ONE OF THE SIDEHOLES OF THE GUIDE CATHETER. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE GUIDE WIRE, THERE WAS A KNOT OUTSIDE OF THE GUIDE CATHETER AND THE PHYSICIAN WAS UNABLE TO REMOVE THE GUIDE WIRE. THE GUIDE CATHETER AND GUIDE WIRE WERE REMOVED AS ONE WITHOUT INCIDENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156150 PT²? WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) H74938931040

    Patients

    Seq Age Sex Outcome Treatment
    1