BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 1660842 · Received April 16, 2010

    Report

    Report Number
    1056128-2010-00008
    Event Type
    Injury
    Date Received
    April 16, 2010
    Report Date
    April 30, 2010
    Manufacturer
    ASCENT HALTHCARE SOLUTIONS
    Product Code
    NLM
    PMA / PMN Number
    K070059
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED TO ASCENT HEALTHCARE SOLUTIONS FOR EVALUATION. ONCE THE DEVICE IS RETURNED AND EVALUATED, A FOLLOW-UP MDR WILL BE SUBMITTED. THIS IS THE FIRST COMPLAINT ASCENT HAS RECEIVED FOR A TROCAR CUTTING AN ARTERY.

    Additional Manufacturer Narrative · 1

    PHOTOGRAPHIC IMAGES OF THE COMPLAINT DEVICE WERE PROVIDED HOWEVER THE DEVICE WAS NOT RETURNED TO ASCENT FOR EVALUATION SO A ROOT CAUSE COULD NOT BE DETERMINED. ASCENT HEALTHCARE SOLUTIONS' INSTRUCTIONS FOR USE STATE: "IMPROPER USE OF THIS PRODUCT CAN RESULT IN LIFE-THREATENING INJURY TO INTERNAL ORGANS AND VASCULATURE. USE EXTREME CAUTION DURING TROCAR INSERTION." "ALTHOUGH MANY TROCAR MODELS ARE BLUNT OR HAVE SAFETY FEATURES, CARE MUST BE TAKEN WHEN INTRODUCING TO AVOID DAMAGE TO MAJOR VESSELS AND OTHER ANATOMIC STRUCTURES." "DIRECT THE TROCAR AWAY FROM MAJOR VESSELS AND OTHER ANATOMIC STRUCTURES." THIS IS THE FIRST COMPLAINT ASCENT HAS RECEIVED FOR A TROCAR CUTTING AN ARTERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VOLUNTARY GYN SURGERY THE PHYSICIAN CUT A BLOOD VESSEL WITH THE TROCAR. WHEN THE TROCAR ACCESSED THE ABDOMINAL CAVITY, THE SURGEON NOTICED BLOOD COMING INTO THE TROCAR. AT THIS TIME, THE PATIENT WAS OPENED UP, AND IT WAS DETERMINED THE ILIAC ARTERY HAD BEEN NICKED. THE PATIENT WAS STABILIZED. THE PATIENT WAS THEN TRANSPORTED TO (B) (6) HOSPITAL (B) (6) WHERE A VASCULAR SURGEON REPAIRED THE ARTERY DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A 105CM ENDOVIVE TWO PORT THROUGH THE PEG JEJUNAL FEEDING TUBE WAS PLACED (B) (6) 2010 FOR THE PURPOSE OF ADMINISTERING MEDICATION (DUODOPA) FOR ADVANCED STAGE PARKINSON'S DISEASE. ACCORDING TO THE COMPLAINANT, POST PROCEDURE ON (B) (6) 2010 THE JEJUNAL TUBE BECAME KINKED AND OCCLUDED. THE DEVICE WAS REPLACED WITH A NEW 105CM ENDOVIVE TWO PORT THROUGH THE PEG JEJUNAL FEEDING TUBE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NLM NLM ASCENT HALTHCARE SOLUTIONS D5LT 200511

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R