BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2831854 · Received November 14, 2012

    Report

    Report Number
    2024168-2012-07180
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    February 2, 2012
    Report Date
    October 23, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED VIA AN INTERNET BLOG POSTING ((B)(6)). IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF A RIGHT FEMORAL ARTERY WAS PERFORMED USING A STARCLOSE SE DEVICE AFTER A HEART CATHETERIZATION PROCEDURE. THE PATIENT STATED: "ON (B)(6) 2012 I HAD A STARCLOSE SE USED AFTER HEART CATH FOR FEMORAL ARTERY RIGHT SIDE, IT WILL BE ONE WEEK TOMORROW AND I HAVE HAD SEVERE LEG CRAMPS ENOUGH TO MAKE MY LEG BUCKLE OUT FROM UNDER ME AND CHRONIC GROIN AND LEG PAIN, WHICH WOKE ME UP 3 TIMES LAST NIGHT, I ENDED UP SPEAKING WITH THE NURSE AS OF COURSE SHE IS THE CONTACT PERSON WHO BASICALLY INFORMED ME THAT THE PAIN IS MY FAULT FOR NOT GETTING UP AND STRETCHING. THE FIRST SURGERY I HAD WAS DONE (B)(6) 2010 AND AN ANGIO-SEAL WAS USED WOW, I WISH I COULD OF TOLD THEM TO ONLY USE AN ANGIO-SEAL BUT HOW DO YOU KNOW?" AS THE NAME OF THE PHYSICIAN WAS NOT PROVIDED, IT IS UNKNOWN IF THE PHYSICIAN HAS BEEN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other