BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2063403 · Received April 19, 2011

    Report

    Report Number
    2024168-2011-02743
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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. TO ENSURE THIS TYPE OF EXPERIENCE IS NOT A RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, A SAMPLING OF FINISHED DEVICES IS TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. IT SHOULD BE NOTED THAT SCAR TISSUE IN THE GROIN WAS THE REPORTED CAUSE FOR THE EXPERIENCED RESISTANCE. THE REPORTED DIFFICULTIES EXPERIENCED DURING THE PROCEDURE APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DIAGNOSTIC PROCEDURE, THE PHYSICIAN INSERTED AN INTRODUCER SHEATH INTO THE RIGHT COMMON FEMORAL ARTERY (RCFA) AND RESISTANCE WAS FELT. THE SHEATH WAS RETRACTED AND WHILE DOING THIS THE PHYSICIAN FELT LIKE SOMETHING HAD BEEN PULLED ALONG WITH THE SHEATH IN THE PATIENT. HE OBSERVED THAT SOME OF THE SHEATH COILS HAD UNRAVELED. A CUT DOWN WAS PERFORMED AND A STARCLOSE SE CLIP, PREVIOUSLY DEPLOYED AT AN UNSPECIFIED TIME, WAS PRESENT AND STILL LOCATED IN THE RCFA. THE CLIP WAS REMOVED, THE DIAGNOSTIC PROCEDURE WAS COMPLETED AND THE ARTERY WAS SURGICALLY CLOSED. IT WAS INDICATED THAT SCAR TISSUE IN THE GROIN CAUSED THE REPORTED RESISTANCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT. THOUGH REQUESTED, 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 87 YR Required Intervention SHEATH: 6 FR ARROW FLEX INTRODUCER SHEATH