BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTSITE DEFLECTABLE CATH

    MDR report key: 2131906 · Received June 16, 2011

    Report

    Report Number
    6000094-2011-01179
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 28, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DQY
    PMA / PMN Number
    K033989
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE CATHETER WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE CATHETER WAS KINKED AND APPEARED DAMAGED AT IMPLANT. THE ANALYST NOTED THAT THE SLITTER WAS NOT RETURNED BUT THE CATHETER WAS SLIT SPIRALLY (TECHNIQUE ISSUE) AND THE CONTROL WIRE WAS SNAGGED. THE CATHETER WAS KINKED AT 7 AND 26CM FROM THE HUB.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT WHEN THE DOCTOR WAS SLITTING THE CATHETER SUDDENLY THERE WAS A "THIN WIRE" VISIBLE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECTSITE DEFLECTABLE CATH LEFT HEART DELIVERY SYSTEM DQY MEDTRONIC S.A. C304S59 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other