BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ SUPER STIFF GUIDEWIRE

    MDR report key: 2025833 · Received March 22, 2011

    Report

    Report Number
    2134265-2011-01065
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K843012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    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.BSC ID: A00271872 TW: 1921606

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. AN EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE DISTAL PART OF THE WIRE WAS ELONGATED AND BENT WITH THE DISTAL END OF THE WIRE INTACT. THE DEVICE PRESENTS A SECTION 5CM IN LENGTH LOCATED 45CM FROM THE DISTAL END WHERE THE COATING IS DETACHED. ANOTHER SECTION 2CM IN LENGTH WAS IDENTIFIED 85CM FROM THE DISTAL END. THE OUTER DIAMETER OF THE WIRE WAS MEASURED AND FOUND TO MEET SPECIFICATION. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A CATHETER EXCHANGE PROCEDURE, A GUIDE WIRE TIP DETACHMENT OCCURRED. THE PHYSICIAN WAS SHAPING THE TIP OF THIS AMPLATZ SUPER STIFF GUIDE WIRE OUTSIDE THE PATIENT WHEN THE TIP DETACHED FROM THE REST OF THE WIRE. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED USING ANOTHER AMPLATZ SUPER STIFF WIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A CATHETER EXCHANGE PROCEDURE, A GUIDE WIRE TIP DETACHMENT OCCURRED. THE PHYSICIAN WAS SHAPING THE TIP OF THIS AMPLATZ SUPER STIFF GUIDE WIRE OUTSIDE THE PATIENT WHEN THE TIP DETACHED FROM THE REST OF THE WIRE. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED USING ANOTHER AMPLATZ SUPER STIFF WIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZ SUPER STIFF GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA M001465230

    Patients

    Seq Age Sex Outcome Treatment
    1