BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2090387 · Received May 16, 2011

    Report

    Report Number
    2024168-2011-03506
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    March 25, 2011
    Report Date
    April 27, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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 RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND IT WAS FULLY CLIP DEPLOYED. THERE WAS NO DAMAGE OR ABNORMALITIES DETECTED DURING THE EXTERNAL EXAMINATION. THE EXTERNAL COMPONENTS WERE IN THE CORRECT POST DEPLOYED POSITIONS. THE DEVICE WAS OPENED TO EXAMINE THE INTERNAL COMPONENTS AND THEY WERE ALSO IN THE CORRECT POST DEPLOYED POSITIONS. THE VESSEL LOCATOR WINGS WERE EXAMINED AND FOUND TO BE NORMAL FOR A DEPLOYED DEVICE AND NOT A CONTRIBUTING FACTOR IN THE EVENT. THERE WERE NO OBSERVATIONS FOUND WITH THE DEVICE THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. BASED ON THE INVESTIGATION FINDINGS, THE REPORTED EXPERIENCE COULD NOT BE CONFIRMED. THE REPORT OF THE NOT CLOSING THE ACCESS SITE CAN BE INFLUENCED BY, BUT NOT LIMITED TO, MANUFACTURING, INCORRECT ANGLE OR POSITIONING AT STEP #4 (CLIP DEPLOYMENT), AS STATED IN THE INSTRUCTIONS FOR USE. HOLDING THE DEVICE AT AN IMPROPER ANGLE DURING CLIP DEPLOYMENT CAN CAUSE INCOMPLETE TISSUE CAPTURE BY THE CLIP RESULTING IN ARTERIAL BLEEDING. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION, IT COULD NOT BE CONCLUSIVELY DETERMINED AS THE CAUSE IN THIS CASE. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY. BASED ON THE INVESTIGATION FINDINGS, THE REPORTED EXPERIENCED DURING THE PROCEDURE AND SUBSEQUENT FAILURE TO ACHIEVE HEMOSTASIS WITH THE DEVICE, APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT DURING USE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. IN ADDITION, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO PREVIOUS INCIDENTS REPORTED FOR DEVICE OPERATES DIFFERENTLY THAN EXPECTED-CLIP. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE DEVICE FAILED TO CLOSE THE ARTERY. MANUAL COMPRESSION WAS APPLIED FOR ONE HOUR TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. 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 010276H

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention