BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2212943 · Received August 16, 2011

    Report

    Report Number
    2024168-2011-05763
    Event Type
    Death
    Date Received
    August 16, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 22, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED DEATH IS A KNOWN ADVERSE EVENT LISTED IN THE MINI TREK INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH UNSTABLE ANGINA ON (B)(6) 2011. THE PATIENT PRESENTED WITH A LOT OF COMPLICATIONS, BOTH ILIAC WERE DISEASED, POST CORONARY ARTERY BYPASS IN RIGHT CORONARY ARTERY, ALL GRAFTS WERE OCCLUDED. THE LEFT CIRCUMFLEX WAS 99% OCCLUDED. ANGIOGRAPHY REVEALED THAT THE MID LEFT ANTERIOR DESCENDING ARTERY HAD A 30% LESION. PLAIN OLD BALLOON ANGIOPLASTY WAS PERFORMED ON THE LESION WITH THE 2.0 X 15 MM MINI TREK BALLOON AT 12 ATMOSPHERES AND THE PATIENT SENT TO THE CRITICAL CARE UNIT (CCU) FOR MONITORING. ON THE MORNING OF (B)(6), 2011, THE PATIENT WAS FOUND TO HAVE EXPIRED IN CCU, THE DEATH WAS UNWITNESSED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0072661

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death