BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGIC TORQUE GUIDEWIRE

    MDR report key: 1910005 · Received November 30, 2010

    Report

    Report Number
    2134265-2010-05330
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K933334
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#: 2134265-2010-05329. IT WAS REPORTED THAT DURING PREPARATION FOR A PERIPHERAL STENTING TREATMENT PROCEDURE THE GUIDE WIRE PERFORATED THE CATHETER WALL. THE LESION WAS LOCATED IN THE LEFT COMMON ILIAC ARTERY. AS THE PHYSICIAN WAS PREPARING THE MAGIC TORQUE GUIDE WIRE, THE TIP OF THE GUIDE WIRE TOUCHED THE MONITOR CONTAMINATING THE GUIDE WIRE. THE CONTAMINATED TIP OF THE MAGIC TORQUE GUIDE WIRE WAS CUT OFF. AS THE 7.0X40X135CM EXPRESS LD ILIAC / BILIARY STENT SYSTEM WAS LOADED ONTO THE MAGIC TORQUE GUIDE WIRE, THE MAGIC TORQUE GUIDE WIRE PERFORATED THE PROXIMAL PORTION OF THE EXPRESS LD SHAFT. THIS EVENT OCCURRED OUTSIDE OF THE PATIENT. ANOTHER 7.0X40X135CM EXPRESS LD ILIAC / BILIARY STENT SYSTEM AND MAGIC TORQUE GUIDE WIRE WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#: 2134265-2010-05329. IT WAS REPORTED THAT DURING PREPARATION FOR A PERIPHERAL STENTING TREATMENT PROCEDURE THE GUIDE WIRE PERFORATED THE CATHETER WALL. THE LESION WAS LOCATED IN THE LEFT COMMON ILIAC ARTERY. AS THE PHYSICIAN WAS PREPARING THE MAGIC TORQUE GUIDE WIRE, THE TIP OF THE GUIDE WIRE TOUCHED THE MONITOR CONTAMINATING THE GUIDE WIRE. THE CONTAMINATED TIP OF THE MAGIC TORQUE GUIDE WIRE WAS CUT OFF. AS THE 7.0X40X135CM EXPRESS LD ILIAC / BILIARY STENT SYSTEM WAS LOADED ONTO THE MAGIC TORQUE GUIDE WIRE, THE MAGIC TORQUE GUIDE WIRE PERFORATED THE PROXIMAL PORTION OF THE EXPRESS LD SHAFT. THIS EVENT OCCURRED OUTSIDE OF THE PATIENT. ANOTHER 7.0X40X135CM EXPRESS LD ILIAC / BILIARY STENT SYSTEM AND MAGIC TORQUE GUIDE WIRE WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGIC TORQUE GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA UNK218

    Patients

    Seq Age Sex Outcome Treatment
    1 STENT: EXPRESS-B-I LD PMTD 7.0X40X135 CM