BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 3122329 · Received May 21, 2013

    Report

    Report Number
    2024168-2013-03196
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 1, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 DEVICE WAS RETURNED FOR EVALUATION. THE SHEATH WAS COMPLETELY SLIT AND WAS DAMAGED AT THE TIP FROM BEING STRETCHED AND STRIKING THE OPEN VESSEL LOCATOR WINGS. THE GARAGE AND PUSHER TUBES WERE PROXIMAL OF THE CARRIER TUBE EXPOSING THE CLIPS LOADED POSITIONS, THE CLIP WAS NOT RETURNED. THE INTERNAL COMPONENT INSPECTION DID NOT DETECT ANY COMPONENT DAMAGE OTHER THAN THE PROXIMALLY DISPLACED GARAGE BLOCK. THE DISPLACED GARAGE BLOCK MAY HAVE CREATED RESISTANCE TO THUMB ADVANCER MOVEMENT BY RUBBING AGAINST THE INNER HANDLE SURFACES. THIS RUBBING COULD CONTRIBUTE TO THE REPORTED NOISE DURING USE. THE STRETCHED SHEATH AND DISPLACE GARAGE BLOCK INDICATES EXCESSIVE RESISTANCE WAS ENCOUNTERED DURING THUMB ADVANCEMENT. BASED ON THE ANALYSIS AND TEST RESULTS THE CAUSE FOR THE DEVICE OPERATING DIFFERENTLY THAN EXPECTED APPEARS TO BE RELATED TO OPERATIONAL CONTEXT. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    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 WITH A 6FR SHEATH, AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, DURING USE THE DEVICE WAS MAKING A "CLICKING" NOISE. IT IS UNKNOWN IF THE CLIP WAS DEPLOYED OR IF THE ACCESS PORTS WERE USED TO REMOVE THE DEVICE. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223938 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 21012K1

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention SHEATH: 6F