BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2143165 · Received June 28, 2011

    Report

    Report Number
    2024168-2011-04533
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    April 25, 2011
    Report Date
    June 7, 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 THAT IT WAS FULLY CLIP-DEPLOYED WITH ALL COMPONENTS IN THE APPROPRIATE POST CLIP-DEPLOYMENT POSITIONS. THE CLIP-FIRING MECHANISM WAS ACTIVATED AND THERE WERE CLIP TINE MARKS ON THE CARRIER TUBE, INDICATING THAT THE CLIP WAS LOADED ONTO THE CARRIER TUBE DURING MANUFACTURING AND FIRED OFF THE DEVICE DURING USE. THE VESSEL LOCATOR WINGS WERE FULLY COLLAPSED AND THE SHEATH WAS FULLY SLIT. THERE WERE NO ABNORMAL OBSERVATIONS THAT COULD PREVENT THE CLIP FROM BEING FIRED AND DELIVERED TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL. BASED ON THE INVESTIGATION FINDINGS, THE REPORTED DEVICE DEPLOYMENT FAILURE COULD NOT BE CONFIRMED AND A CAUSE RELATED TO THE DEVICE COULD NOT BE DETERMINED. CONTRIBUTING FACTORS FOR THE REPORTED EXPERIENCE COULD INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, ANATOMICAL CONDITIONS, DEPLOYMENT TECHNIQUE AND/OR PATIENT MOVEMENTS. THE RETURNED CONDITION OF THE DEVICE INDICATED THAT IT WAS PROPERLY DEPLOYED TO FIRE THE CLIP OFF THE DEVICE DURING USE AS DESIGNED. THERE WERE NO CHALLENGING ANATOMICAL CONDITIONS REPORTED OR INFORMATION THAT SUGGESTED INCORRECT TECHNIQUE, OR PATIENT BODILY MOVEMENTS DURING THE PROCEDURE THAT COULD HAVE CONTRIBUTED TO THE CLIP BEING FIRED OFF-TARGET RESULTING IN THE INABILITY TO ACHIEVE HEMOSTASIS. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED AS A RESULT OF THIS INVESTIGATION. A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THIS LOT WAS PERFORMED AND THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE USING A STARCLOSE SE OF AN UNSPECIFIED VESSEL AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE DEVICE FAILED TO DEPLOY. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. 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 030206H

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention