BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2103403 · Received May 26, 2011

    Report

    Report Number
    2024168-2011-03707
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 2, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FULLY CLIP-DEPLOYED WITH ALL EXTERNAL AND INTERNAL COMPONENTS IN APPROPRIATE POST CLIP-DEPLOYMENT POSITIONS. THE THUMB ADVANCER STROKE AND SHEATH SLIT WERE COMPLETE. THE CLIP WAS FIRED AND THE LOCATOR WINGS WERE FULLY COLLAPSED. THERE WERE NO ABNORMAL OBSERVATIONS THAT COULD PREVENT THE CLIP FROM BEING FULLY DELIVERED TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL. HOWEVER, THE PATIENT BODILY MOVEMENTS DURING THE PROCEDURE CAN CAUSE THE CLIP TO LAND AT AN UNINTENDED SITE. BASED ON THE INVESTIGATION FINDINGS, THE DEVICE PERFORMED AS INTENDED. THE REPORTED PRODUCT EXPERIENCE COULD NOT BE CONFIRMED AND NO DEFINITIVE CAUSE COULD BE DETERMINED DUE TO THE CLIP NOT BEING RETURNED WITH THE DEVICE. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. A REVIEW OF THE PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT DATABASE FOR THIS LOT WAS PERFORMED AND THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. TO ENSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO AN INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. ESTIMATED DATE OF EVENT (REPORTED AS UNKNOWN). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE USING THE STARCLOSE SE DEVICE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE CLIP "DID NOT TAKE" AND MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. 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 010396H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention