BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STABLEMAPR

    MDR report key: 2131378 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10638
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    March 8, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DRF
    PMA / PMN Number
    K981642
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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 CATHETER 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 DEVICE WAS RETURNED, ANALYZED AND PRIMARY ANALYSIS REVEALED THAT THE MANIPULATOR WIRE WAS BROKEN. THERE WAS ALSO OUT-OF PLANE DEFLECTION AND THE CATHETER WAS KINKED. VISUAL ANALYSIS REVEALED THAT THERE WERE KINKS IN THE SHAFT AT 93, 94, AND 101 CM FROM THE HANDLE, AND THIS WOULD HAVE CONTRIBUTED TO THE INABILITY TO FORM THE CORRECT SHAPE. THE BAND ELECTRODE WAS FLATTENED AND SHAFT WAS TWISTED. THERE WAS APPARENT IMPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS PLACED IN THE RIGHT ATRIUM AND THE CATHETER ELECTRODES BECAME FUSED. THE CATHETER WAS UNABLE TO RETURN TO ORIGINAL SHAPE. ANOTHER CATHETER WAS PLACED IN THE INFERIOR VENA CAVA (IVC) TO PULL THE CATHETER APART, AND THE CATHETER WAS THEN REMOVED FROM THE PATIENT. THE PATIENT REQUIRED PERICARDIOCENTESIS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS PLACED IN THE RIGHT ATRIUM AND THE CATHETER ELECTRODES BECAME FUSED. THE CATHETER WAS UNABLE TO RETURN TO ORIGINAL SHAPE. ANOTHER CATHETER WAS PLACED IN THE INFERIOR VENA CAVA (IVC) TO PULL THE CATHETER APART, AND THE CATHETER WAS THEN REMOVED FROM THE PATIENT. THE PATIENT REQUIRED PERICARDIOCENTESIS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STABLEMAPR ABLATION DIAGNOSTIC CATHETER DRF MEDTRONIC PUERTO RICO, INC. 04402SM ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O| R