BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1980447 · Received February 7, 2011

    Report

    Report Number
    2024168-2011-00725
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED EXCHANGE SHEATH YIELDED THE FOLLOWING OBSERVATIONS: THERE WAS A SLIT ON THE SHEATH DISTAL TO THE STRAIN RELIEF AND CUTTER MARK ON THE HUB WHICH IS AN INDICATION THAT THE HUB MADE CONTACT WITH THE CUTTER. DURING THE INVESTIGATION, THE EXCHANGE SHEATH WAS LOADED IN A PROXY DEVICE WITHOUT A PROBLEM. HOWEVER, IT WAS REPORTED THAT THE OPERATOR WAS NOT TRAINED. THIS IS A VIOLATION OF THE INSTRUCTIONS FOR USE. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD (LHR) DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS (NCMRS) ASSOCIATED WITH THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THAT IT WAS PARTIALLY DEPLOYED AND THE EXCHANGE SHEATH WAS NOT ATTACHED TO THE CLIP APPLIER. THE LEADING EDGE OF THE CUTTER WAS DAMAGED. THERE WAS A SLIT ON THE SHEATH DISTAL TO THE STRAIN RELIEF AND CUTTER MARK ON THE HUB WHICH IS AN INDICATION THAT THE HUB MADE CONTACT WITH THE CUTTER. THESE FINDINGS ARE CONSISTENT WITH AND CONFIRM THE REPORTED EXPERIENCE. DURING THE INVESTIGATION, THE EXCHANGE SHEATH WAS LOADED IN A PROXY DEVICE WITHOUT A PROBLEM. THE CONDITION OF THE RETURNED DEVICE IS CONSISTENT WITH THE DEVICE BEING DEPLOYED AT SOME POINT THROUGH VESSEL LOCATOR DEPLOYMENT (STEP # 2) WITHOUT THE ENGAGING OF THE SHEATH TO THE STARCLOSE SE DEVICE (STEP # 1) BEING COMPLETED. EACH CUTTER IS INSPECTED 100% DURING FINAL INSPECTION VISUALLY TO VERIFY THAT THE SHEATH CUTTER IS NOT BENT AWAY FROM THE NYLON TUBE, THAT THERE IS NO SIGNIFICANT SHEATH CUTTER DAMAGE AND ALSO TO VERIFY THE OUTSIDE CORNER AND CUTTER EDGE IS SHARP. PRIOR TO FINAL INSPECTION AND DURING ASSEMBLY THE SHARPNESS, SHAPE AND POSITION OF THE CUTTER IS INSPECTED TO VERIFY IT IS WITHIN SPECIFICATION. THE POSSIBLE CAUSE FOR THE EXCHANGE SHEATH RELEASING FROM THE DEVICE IS NOT PROPERLY LOADING THE EXCHANGE SHEATH INTO THE DEVICE, PREVENTING THE HUB TO SIT PROPERLY AND ENGAGE THE HUB RETENTION FEATURE, THUS NO AUDIBLE CLICK WAS HEARD. IT WAS REPORTED THAT THE OPERATOR WAS NOT TRAINED IN THE USE OF THE STARCLOSE SE DEVICE AS INDICATED IN THE INSTRUCTIONS FOR USE. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD (LHR) DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS (NCMRS) ASSOCIATED WITH THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. OPERATOR NOT TRAINED/FAILURE TO FOLLOW STEPS/INSTRUCTIONS. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN UNTRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL, CAROTID PROCEDURE. REPORTEDLY, WHILE CONNECTING THE STARCLOSE SE EXCHANGE SHEATH TO THE CLIP APPLIER, THERE NO WAS AUDIBLE "CLICK" HEARD. THE PHYSICIAN WAS ADVISED TO DISCONTINUE BUT HE CHOSE TO PROCEED WITH THE USE OF THE DEVICE. DURING SHEATH SPLITTING, THE SHEATH RELEASED FROM THE DEVICE. AS PER THE INSTRUCTIONS FOR USE, THE DEVICE WAS REMOVED FROM THE ANATOMY USING THE SAFETY RELEASE BUTTON AND THE ACCESS PORTS. A SECOND STARCLOSE SE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 850476H

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention