BEUDAMED
    FDA Adverse Event Death Summary report: N

    GLIDER PTCA BALLOON CATHETER 2.5X12MM

    MDR report key: 2967834 · Received January 25, 2013

    Report

    Report Number
    3008089360-2013-00001
    Event Type
    Death
    Date Received
    January 25, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 26, 2012
    Manufacturer
    TRIREME MEDICAL INC.
    Product Code
    LOX
    PMA / PMN Number
    K111544
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTION AND LOT HISTORY RECORDS FOR LOT FC120423003 AND THE SUBASSEMBLIES USED IN ITS MANUFACTURE WERE REVIEWED. NO OUT OF SPECIFICATION FINDINGS WERE OBSERVED. RETURN OF THE DEVICE WAS REQUESTED BUT THE DEVICE HAD BEEN DISPOSED. RELEVANT ANGIOGRAMS WERE REQUESTED BUT HAVE NOT YET ARRIVED. THE INTERNAL INVESTIGATION IS ON-GOING. A F/U MDR WILL BE FILED AFTER RECEIPT AND REVIEW OF THE ANGIOGRAMS AND COMPLETION OF THE INTERNAL INVESTIGATION.

    Description of Event or Problem · 1

    AN EVENT OCCURRED THAT WAS REPORTED AS A PERFORATION AT THE OSTIUM OF THE DIAGONAL BRANCH IN A CASE WHERE GLIDER PTCA AND SEVERAL OTHER MEDICAL DEVICES WERE USED. THERE WAS SOME RESISTANCE FELT DURING CROSSING TO THE DIAGONAL BRANCH. THE GLIDER DEVICE WAS INFLATED TWICE. THE FIRST INFLATION OF THE GLIDER WAS AT THE OSTIUM OF THE DIAGONAL TO 4 ATMOSPHERES. A SUBSEQUENT ANGIOGRAM REVEALED AN ABNORMAL APPEARANCE TO THE PROXIMAL DIAGONAL. LATER REVIEW OF THE ANGIO DETERMINED THAT THERE WAS A PERFORATION AT THAT POINT. THE GLIDER WAS THEN ADVANCED SLIGHTLY AND RE-INFLATED TO NOMINAL PRESSURE. THE SUBSEQUENT ANGIOGRAM REVEALED A VERY LARGE FREE-FLOWING PERFORATION IN THE VICINITY OF THE PROXIMAL/OSTIAL DIAGONAL. THE EMERGENCY PERICARDIOCENTESIS FOLLOWED, A COVERED STENT WAS PLACED. THE PT DEVELOPED CARDIOGENIC SHOCK AND ULTIMATELY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36241 GLIDER PTCA BALLOON CATHETER 2.5X12MM PTCA BALLOON CATHETER LOX TRIREME MEDICAL INC. FC120423003

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death PROWATER WIRE| PILOT 150 GUIDEWIRE