BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2032881 · Received March 29, 2011

    Report

    Report Number
    2024168-2011-02125
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 4, 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 DEVICE FOUND THAT IT WAS FULLY CLIP DEPLOYED. THE ANALYSIS FOUND THAT THE EXCHANGE SHEATH HAD NOT BEEN CORRECTLY ATTACHED TO THE CLIP APPLIER. THE HUB NOT BEING CORRECTLY ATTACHED TO THE CLIP APPLIER BEFORE DEPLOYMENT; CAUSED THE SHEATH TO STRETCH AND SEPARATE FROM THE DEVICE DAMAGING THE DISTAL TIP DURING THUMB ADVANCEMENT. BASED ON THESE FINDING THE REPORTED EXPERIENCE OF THE SHEATH SEPARATING DEVICE DURING REMOVAL IS CONFIRMED. DURING TESTING THE EXCHANGE SHEATH WAS ATTACHED TO THE CLIP APPLIER, THE AUDIBLE CLICK WAS HEARD WITHOUT DIFFICULTY. DURING THE INTERNAL OBSERVATION THE VESSEL LOCATOR WINGS WERE FOUND BENT. BASED ON THE ANALYSIS THE DEPLOYMENT STEPS WERE NOT COMPLETED CORRECTLY. FACTORS THAT MAY CONTRIBUTE TO THE BENT LOCATOR WINGS AND STRETCHED SHEATH; RADIAL FORCE CONSTRICTION MAY INCLUDE A TIGHT TISSUE TRACT OR ANATOMICAL CONDITIONS. DURING CLIP DEPLOYMENT THE VESSEL LOCATORS ARE DESIGNED TO AUTOMATICALLY COLLAPSE SO AS NOT TO INTERFERE WITH THE CLIP DEPLOYMENT; HOWEVER, THE VESSEL LOCATOR WINGS OF THIS DEVICE WERE BENT. THE MOST PROBABLE ROOT CAUSE FOR THE BENT LOCATOR WINGS IS DUE TO TISSUE COMPRESSED BETWEEN THE TUBES AND OPEN LOCATORS. THIS CREATED DISTAL FORCE DURING THUMB ADVANCEMENT, BENDING THE LOCATOR WINGS. BASED ON THE ANALYSIS AND THE INSPECTION CRITERIA THE ROOT CAUSE FOR THE SEPARATION OF THE EXCHANGE SHEATH DURING DEPLOYMENT IS DUE TO A FAILURE TO FOLLOW THE INSTRUCTION FOR USE. NO MANUFACTURING OR QUALITY INSPECTION DEFICIENCY WAS DETECTED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS (LHR) DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS (NCMR) ASSOCIATED WITH THIS LOT. IN ADDITION, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER PREVIOUS INCIDENTS REPORTED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, DURING THUMB ADVANCEMENT (STEP 3), THE SHEATH SPLIT. BEFORE CLIP DELIVERY (STEP 4), THE SHEATH WAS OBSERVED TO BE SEPARATED FROM THE DEVICE. ON DEVICE REMOVAL, THE VESSEL LOCATOR WINGS WERE OBSERVED TO BE CLOSED. MANUAL COMPRESSION WAS APPLIED 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 950396H

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention