BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2131122 · Received June 16, 2011

    Report

    Report Number
    2024168-2011-04239
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    April 13, 2011
    Report Date
    May 25, 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
    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 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 PARTIALLY DEPLOYED WITH THE VESSEL LOCATOR WINGS IN THE OPEN POSITION. THE PLUNGER WAS STILL ENGAGED WITH THE RELEASE ROD, WHICH RESULTED IN THE VESSEL LOCATOR WINGS BEING IN THE OPENED POSITION. THE THUMB ADVANCER WAS APPROXIMATELY 2 CM DISTAL OF THE START POSITION AND SHEATH SLITTING HAD BEEN STOPPED APPROXIMATELY 2 CM DISTAL OF THE STRAIN RELIEF. INTERNAL INSPECTION OF THE DEVICE COMPONENTS REVEALED THEY WERE IN THE CORRESPONDING EXTERNAL POSITIONS AND UNDAMAGED. DURING TESTING, THUMB ADVANCEMENT WAS COMPLETED, COMPLETELY SLITTING THE SHEATH WITHOUT DIFFICULTY. THE DEVICE WAS RETURNED WITH THE SAFETY RELEASE ENGAGED AND THE VESSEL LOCATOR WINGS IN THE OPENED POSITION. BASED ON THE ANALYSIS AND THE TEST RESULTS THE REPORTED TENSION FELT DURING SHEATH SPLITTING COULD NOT BE CONFIRMED. THE CONDITION OF THE RETURNED DEVICE SUGGESTS THAT AFTER THE LOCATOR WINGS WERE DEPLOYED AND DURING THUMB ADVANCEMENT, EXCESSIVE FORCE MAY HAVE BEEN USED RETRACTING THE DEVICE AGAINST THE ARTERIAL WALL. THE INSTRUCTIONS FOR USE (IFU) INSTRUCTS THE USER TO MAINTAIN THE LEFT HAND ON THE STABILIZER TO STABILIZE THE DEVICE AT THE ANGLE OF THE TISSUE TRACT, GENTLY RETRACT THE DEVICE WITH THE RIGHT HAND UNTIL SLIGHT RESISTANCE IS FELT. THE GOAL IS TO PLACE THE LOCATOR WINGS AGAINST THE ANTERIOR SURFACE OF THE ARTERIAL WALL TO LOCATE THE ACCESS SITE WITHOUT APPLYING TENSION ON THE ARTERY. IT COULD NOT BE CONFIRMED IF EXCESSIVE FORCE WAS USED IN POSITIONING THE WINGS AGAINST THE ARTERIAL WALL. THE DEVICE PRESENTED NO EVIDENCE OF RESISTANCE AND A CAUSE FOR THE REPORTED EXPERIENCE COULD NOT BE CONFIRMED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THE REPORTED EVENT OF FAILURE TO DEPLOY THE THUMB ADVANCER, THAT COULD HAVE CONTRIBUTED TO THIS EVENT. BASED ON THE ANALYSIS, TEST RESULTS AND INSPECTION CRITERIA THE REPORTED FAILURE TO DEPLOY THE THUMB ADVANCER EXPERIENCED DURING USE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT DURING USE OF THE PRODUCT. THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY DEFICIENCY. NO MANUFACTURING OR QUALITY INSPECTION ISSUE WAS DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, TENSION WAS FELT DURING SHEATH SPLITTING AND THE SHEATH COULD NOT BE COMPLETELY SPLIT. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, THE SAFETY RELEASE MECHANISM WAS USED TO SUCCESSFULLY FACILITATE DEVICE REMOVAL. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO ADVERSE PATIENT EFFECTS 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 880286H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention