BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 1884468 · Received October 19, 2010

    Report

    Report Number
    2953144-2010-02526
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 24, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROSTAR XL SUTURE-MEDIATED CLOSURE (PART 12322-02, LOT 790166H) INDICATED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROSTAR XL DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE USING A PERCLOSE TECHNIQUE OF THE PROXIMAL FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, ONE OF THE SUTURES HAD COME OUT OF THE ARTERIAL PORT AND THE DEVICE WAS NOT DEPLOYED. ANOTHER PROSTAR XL WAS USED. AFTER THE SUTURES WERE DEPLOYED, RESISTANCE WAS FELT WHEN THE 18F SHEATH WAS ADVANCED IN THE ARTERIAL LUMEN AND THE GREEN SUTURE WAS REPEATEDLY PULLED IN. AS A RESULT, THE GREEN SUTURE WAS REMOVED LEAVING THE WHITE SUTURE IN THE ARTERY. IT WAS NOT SPECIFIED IF THE WHILE SUTURE ACHIEVED HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PT SEQUELA. NO ADDITIONAL INFO WAS PROVIDED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS ELEVATED ACCUTNL RESULTS FOR TWO PATIENTS ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF GENERATED BY THE ACCESS 2 IMMUNOASSAY ANALYZER. THE SAMPLES WERE REPEATED AND LOWER RESULTS WERE OBTAINED. THE ELEVATED RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTAR XL SUTURE-MEDIATED CLOSURE SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR-VASCULAR SOLUTIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention PART 12322-02, LOT 790166H| PROSTAR XL SUTURE-MEDIATED CLOSURE: