BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2151877 · Received July 6, 2011

    Report

    Report Number
    2024168-2011-04783
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 15, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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. ESTIMATED DATE OF EVENT (REPORTED AS OCCURRING LAST WEEK). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: INVESTIGATION OF THE RETURNED DEVICE FOUND THAT IT WAS PARTIALLY DEPLOYED. THE THUMB ADVANCEMENT AND SHEATH SLITTING HAD NOT BEEN COMPLETED. THE PLUNGER WAS ENGAGED AND THE VESSEL LOCATOR WINGS WERE IN THE OPENED POSITIONS DUE TO THE ENGAGED PLUNGER. DURING TESTING, THE DEVICE WAS OPENED AND THE INTERNAL COMPONENTS WERE FOUND UNDAMAGED AND IN THE CORRESPONDING POSITIONS TO THE EXTERNAL. THE DEVICE WAS CLEANED, FULLY DEPLOYED AND FUNCTIONED NORMALLY. THE THUMB ADVANCER STROKE AND SHEATH SLITTING WERE BOTH COMPLETED WITHOUT RESISTANCE. THERE WAS NO DAMAGE OR PRODUCT DEFICIENCY DETECTED. THE CAUSE FOR THE REPORTED RESISTANCE DURING THUMB ADVANCEMENT AND SUBSEQUENT FAILURE TO FULLY DEPLOYED THIS DEVICE COULD NOT BE DETERMINED AND THE REPORTED RESISTANCE COULD NOT BE CONFIRMED. THE REPORT OF THE DEVICE COMING OUT OF THE ARTERY BEFORE COMPLETING THUMB ADVANCEMENT INDICATES THAT EXCESSIVE TENSION MAY HAVE BEEN APPLIED CAUSING THE DEVICE TO PULL OUT OF THE ARTERY DURING THUMB ADVANCEMENT. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE STATES 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 AND THE ARTERY. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED IN THIS CASE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. IN ADDITION, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER PREVIOUS INCIDENTS REPORTED FOR DEVICE OPERATED DIFFERENTLY THAN EXPECTED, LOSS OF ARTERIAL ACCESS OR FOR FAILURE TO DEPLOY THE THUMB ADVANCER. BASED ON THE INVESTIGATION AND REPORTED INFORMATION, THE REPORTED DIFFICULTY APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE DEVICE AND NOT A PRODUCT QUALITY DEFICIENCY. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC MANUFACTURING OR PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING THE STARCLOSE SE AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, IT WAS DIFFICULT TO ADVANCE THE THUMB ADVANCER AND IT FELT STIFF. THE DEVICE POPPED OUT OF THE ARTERY. THE SHEATH HAD SPLIT HALF WAY. MANUAL ARTERIAL COMPRESSION WAS USED. THERE WAS NO ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS PROFICIENT IN THE USE OF THE DEVICE. 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 040296H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6F