BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUGE GUIDE WIRE

    MDR report key: 2962282 · Received February 14, 2013

    Report

    Report Number
    2134265-2013-00748
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K973945
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.: 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).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#2134265-2013-00722 AND MDR# 2134265-2013-00684. IT WAS REPORTED THAT DURING A LOWER EXTREMITY INTERVENTIONAL PROCEDURE, THE CATHETER BECAME ENTRAPPED ON THE WIRE. THE TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY. THE 2.0 X 100MM COYOTE BALLOON CATHETER WAS BEING REMOVED FROM THE PATIENT, WHEN IT WAS ENTRAPPED ON THE .014 LUGE GUIDE WIRE. THE GUIDE WIRE AND BALLOON CATHETER WERE REMOVED TOGETHER. A 2.0 X 220MM COYOTE BALLOON WAS BEING REMOVED FROM THE HOOP WHEN THE PHYSICIAN MET INCREASED RESISTANCE, UNTIL THE BALLOON BEGAN TO STRIP OFF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID# 2134265-2013-00722 AND MDR# 2134265-2013-00684. IT WAS REPORTED THAT DURING A LOWER EXTREMITY INTERVENTIONAL PROCEDURE, THE CATHETER BECAME ENTRAPPED ON THE WIRE. THE TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY. THE 2.0 X 100 MM COYOTE BALLOON CATHETER WAS BEING REMOVED FROM THE PATIENT, WHEN IT WAS ENTRAPPED ON THE .014 LUGE GUIDE WIRE. THE GUIDE WIRE AND BALLOON CATHETER WERE REMOVED TOGETHER. A 2.0 X 220 MM COYOTE BALLOON WAS BEING REMOVED FROM THE HOOP WHEN THE PHYSICIAN MET INCREASED RESISTANCE, UNTIL THE BALLOON BEGAN TO STRIP OFF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66127 LUGE GUIDE WIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) UNK496

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR