BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRMAP CATHETER, 60MM, EU

    MDR report key: 4619188 · Received March 17, 2015

    Report

    Report Number
    3010850305-2015-00003
    Event Type
    Malfunction
    Date Received
    March 17, 2015
    Date of Event
    February 17, 2015
    Report Date
    March 18, 2015
    Manufacturer
    MEDFACT ENGINEERING GMBH
    Product Code
    MTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS RETURNED TO (B)(4) ON MARCH 2, 2015 AND SAMPLE EVAL/INSPECTION WAS COMPLETED ON MARCH 9, 2015. VISUAL INSPECTION OF THE RETURNED CATHETER CONFIRMED ONE SPLINE BROKEN AT DISTAL END. THERE IS NO INTRODUCER DAMAGE, NO PEBAX DAMAGE, AND NO MISSING PARTS WERE OBSERVED. AS OF MARCH 2015, FURTHER INVESTIGATION IS BEING CONDUCTED AT TOPERA. RECORDS OF THE RAW MATERIAL USED TO MANUFACTURE THIS LOT WERE ALSO REVIEWED AND NO ABNORMALITIES WERE FOUND. NO EVIDENCE OF MFG DEFECTS WERE FOUND BASED ON THE VISUAL INSPECTION AND BATCH RECORD REVIEW PERFORMED.

    Description of Event or Problem · 1

    TOPERA COMPLAINT (B)(4) WAS RECEIVED FOR ONE 60MM MAPPING CATHETERS THAT EXHIBITED ONE BROKEN SPLINE AT THE DISTAL END OF THE CATHETER AT (B)(6). THE FIRMAP 60MM MAPPING CATHETER USED TO MAP THE PT'S LEFT ATRIUM WAS OBSERVED TO HAVE ONE SPLINE BROKEN FROM THE DISTAL TIP DURING CLEANING OF THE CATHETER 2 HOURS AFTER THE PROCEDURE. NO ABNORMALITY WAS OBSERVED DURING THE PROCEDURE AND THE PHYSICIAN DID NOT OBSERVE ANY SPLINE BEING OUT OF PLACE DURING THE PROCEDURE VIA X-RAY OR ICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182652 FIRMAP CATHETER, 60MM, EU MAPPING CATHETER MTD MEDFACT ENGINEERING GMBH EU-AR064060 60EU220514

    Patients

    Seq Age Sex Outcome Treatment
    1