BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT2 GUIDE WIRE

    MDR report key: 2032720 · Received March 29, 2011

    Report

    Report Number
    2134265-2011-00977
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    December 22, 2010
    Report Date
    March 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K030617
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6). DEVICE EVALUATED BY MFR: THE UNIT WAS NOT RETURNED BY THE CUSTOMER; THEREFORE, NO PRODUCT ANALYSIS COULD BE PERFORMED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS USER RELATED AS THE DEVICE WAS NOT USED IN ACCORDANCE WITH THE DFU. THIS DEVICE WAS USED FOR A UROLOGICAL PROCEDURE. PER THE PRODUCT DFU: "BOSTON SCIENTIFIC GUIDEWIRES ARE INTENDED TO FACILITATE THE PLACEMENT OF BALLOON DILATATION CATHETERS OR OTHER INTERVENTIONAL THERAPEUTIC DEVICES DURING PTCA, PTA, OR OTHER INTRAVASCULAR INTERVENTIONAL PROCEDURES. CAREFULLY CHECK AND MATCH THERAPEUTIC DEVICE COMPATIBILITY TO THE WIRE PRIOR TO USE". (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REMOVAL OF A URETHRAL J-STENT, GUIDE WIRE TIP DETACHMENT OCCURRED. THE PATIENT HAD AN UNKNOWN MANUFACTURER'S URETHRAL J-STENT PLACED AT AN UNKNOWN DATE. THE J-STENT WAS REPORTED TO BE "STUCK". DUE TO THE LIMITED SPACE TO PASS THE J-STENT, A 0.014" PT2 GUIDE WIRE WAS SELECTED TO CROSS THE STENT. "DR USED A VERY SOFT CORONARY WIRE IN A PROCEDURE WHERE THERE ARE LOTS OF CRYSTALS AND STICKY FLUID". THE PT2 GUIDE WIRE WAS UNABLE TO PASS THE STENT. WHILE WITHDRAWING THE GUIDE WIRE, IT BECAME STUCK IN THE CRYSTALIZATION IN THE URETHRA AND APPROX 5MM OF THE TIP STRETCHED AND BROKE OFF INSIDE THE PATIENT. THE FRAGMENT REMAINS IN THE PATIENT. IT IS THE PHYSICIAN'S OPINION THAT "THE REMAINING TIP WON'T DO ANY HARM AND WON'T PERFORATE, SINCE ITS ONLY WAY TO PASS IS THROUGH THE URETHER". THE PATIENT'S CONDITION POST PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PT2 GUIDE WIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA UNK507

    Patients

    Seq Age Sex Outcome Treatment
    1 Other