BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2143184 · Received June 28, 2011

    Report

    Report Number
    2024168-2011-04538
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    May 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED FOUND THAT IT WAS FULLY CLIP DEPLOYED. THE INTERNAL AND EXTERNAL EXAMINATION FOUND ALL OF THE COMPONENTS IN THE CORRECT POST DEPLOYMENT POSITIONS AND UNDAMAGED. DURING TESTING, THE DEVICE WAS CLEANED AND RESET AND RE-DEPLOYED RESULTING IN A NORMALLY FUNCTIONING DEVICE. THE CLIP HAD BEEN DEPLOYED AS EVIDENCED BY THE CLIP TINE WITNESS MARKS AT THE DISTAL-END OF THE CARRIER TUBE AND WAS NOT RETURNED WITH THE DEVICE. THERE WAS NOTHING DETECTED WITH THE RETURNED DEVICE THAT WOULD CONTRIBUTE TO THE REPORTED EXPERIENCE OF CONTINUED BLEEDING AFTER DEPLOYMENT. THEREFORE, THE REPORTED EXPERIENCE COULD NOT BE CONFIRMED. THE DEVICE MISFIRING OR FAILING TO DELIVER THE CLIP AT THE INTENDED SITE CAN BE INFLUENCED BY MANY FACTORS, SUCH AS RETRACTION OF THE DEVICE DURING CLIP DEPLOYMENT, WHICH CAN RESULT IN INCOMPLETE TISSUE CAPTURE AND CLIP DEPLOYMENT ABOVE THE ARTERY. IN ADDITION, FAILING TO RAISE THE DEVICE THE DEVICE FROM 45 DEGREES TO 60-75 DEGREES PRIOR TO CLIP DEPLOYMENT MAY RESULT IN INCOMPLETE TISSUE BEING CAPTURED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC MANUFACTURING OR PRODUCT QUALITY DEFICIENCY. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO A 100% 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. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EXPIRATION DATE CORRECTED FROM 03/31/2011 TO 03/31/2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, BLEEDING CONTINUED. WHEN THE DEVICE WAS REMOVED, THE CLIP WAS NOTED TO BE DEPLOYED IN THE LOCATOR WINGS. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THE NURSE IS TRAINED IN THE USE OF THE STARCLOSE SE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. 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 70 YR Required Intervention PROCEDURAL SHEATH 6F