BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2189931 · Received August 3, 2011

    Report

    Report Number
    2024168-2011-05477
    Event Type
    Injury
    Date Received
    August 3, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 PROVIDED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, WHICH MAY HAVE ASSISTED IN THIS INVESTIGATION. WITHOUT THE DEVICE ANALYSIS, A CAUSE FOR THE REPORTED LOSS OF ARTERIAL ACCESS COULD NOT BE DETERMINED. LOSS OF ARTERIAL ACCESS CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, A MANUFACTURING, USER TECHNIQUE AND PATIENT ANATOMICAL CONDITIONS. DEPLOYMENT OF THE DEVICE IN A CHALLENGING ANATOMY MAY CAUSE LOSS OF ARTERIAL ACCESS. THE PATIENT WAS REPORTED TO HAVE PERIPHERAL VASCULAR DISEASE AND PRIOR ARTERIOTOMY IN THE TARGET GROIN; NO CALCIFICATION WAS NOTED. THESE ANATOMICAL CONDITIONS MAY HAVE CONTRIBUTED TO THE REPORTED LOSS OF ARTERIAL ACCESS. POTENTIAL CONTRIBUTING FACTORS FOR USER TECHNIQUE INCLUDE, INCOMPLETE STROKE OF THE PLUNGER, APPLYING EXCESSIVE TENSION AGAINST THE LOCATOR WINGS, OR AN INADEQUATE NICK AND SPREAD INCISION MAY RESULT IN LOSS OF ARTERIAL ACCESS. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. DURING MANUFACTURING, ALL DEVICES ARE VISUALLY INSPECTED. IN ADDITION, A SAMPLING OF FINISHED DEVICES IS DESTRUCTIVELY TESTED, INCLUDING THE STABILITY OF THE DEVICE TO VERIFY THE FUNCTIONALITY OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE DEVICE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER THE THUMB ADVANCER WAS ADVANCED TO COMPLETION TO SPLIT THE SHEATH, AND AS THE DEVICE WAS MANEUVERED TO THE INSTRUCTED ANGLE OF 60 TO 75 DEGREES BEFORE CLIP DEPLOYMENT, THE DEVICE CAME OUT OF THE ARTERY. MANUAL ARTERIAL COMPRESSION WAS APPLIED FOR 20 MINUTES. THERE WAS NO ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE STARCLOSE SE. 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 050106H

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention SHEATH: 6FHEPARIN