BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2061449 · Received April 18, 2011

    Report

    Report Number
    2024168-2011-02708
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THAT THE CLIP-FIRING MECHANISM WAS ACTIVATED AND THERE WERE CLIP TINES MARKS ON THE CARRIER TUBE. THIS IS INDICATIVE OF THE CLIP BEING LOADED ON THE CARRIER TUBE DURING MANUFACTURING AND FIRED DURING DEPLOYMENT, CONTRADICTING THE REPORTED EXPERIENCE. AN ATTEMPT WAS MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE SITE; HOWEVER, THE RETURNED CONDITION REVEALED NO INDICATION THAT THE DEVICE WAS MANIPULATED AFTER DEPLOYMENT AS STATED. THE DEVICE WAS RETURNED WITHOUT HAVING THE EXCHANGE SHEATH SYSTEM INSTALLED ON IT. IT IS POSSIBLE THAT THE HUB OF THE SHEATH WAS NOT FIRMLY AND SECURELY ENGAGED WITH THE DEVICE DURING HUB-TO-DEVICE INSTALLATION, RESULTING IN THE SHEATH SYSTEM BEING DISTALLY PUSHED OFF THE DEVICE WHILE ADVANCING THE THUMB ADVANCER TO ADVANCE THE DELIVERY TUBESET AND SPLIT THE SHEATH. HOWEVER, THIS COULD NOT BE CONFIRMED AS THE SHEATH WAS NOT RETURNED WITH THE DEVICE. INSPECTION OF THE RETURNED DEVICE SUGGESTED THAT THE LOCATOR WINGS WERE INITIALLY BENT DURING THUMB ADVANCER DEPLOYMENT. BUT IT COULD NOT DETERMINE WHETHER THE LOCATOR WINGS WERE BENT DUE TO TISSUE COMPACTION THAT EXERTED A DISTAL FORCE ON THE WINGS WHILE IN THE TISSUE TRACT OR THE WINGS MIGHT HAVE BEEN COMPRESSED AS THE EXCHANGE SHEATH SYSTEM BEING PUSHED OFF OVER THEM. BENT WINGS WOULD PREVENT THEM FROM FULLY COLLAPSING INTO THE DELIVERY TUBESET AND COULD BECOME DETACHED FROM THE DISTAL RETAINING RING AS OBSERVED WHEN THE CLIP WAS FIRED. ALL BROKEN WINGS REMAINED SECURELY ATTACHED WITHIN THE LOCATOR. ALSO, BENT WINGS COULD RESULT IN DIFFICULT DEVICE REMOVAL; HOWEVER, THIS WAS NOT REPORTED. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE ROOT CAUSE FOR THE BROKEN LOCATOR WINGS COULD NOT BE DETERMINED. BUT DAMAGED LOCATOR WINGS COULD PREVENT THE CLIP FROM BEING DELIVERED TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL WHEN THE CLIP-FIRING MECHANISM WAS ACTIVATED. A REVIEW OF THE PRODUCT LOT HISTORY RECORD (LHR) DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. A QUERY OF THE COMPLAINT DATABASE FOR THIS LOT REVEALED NO INCIDENTS WITH SIMILAR REPORTED PRODUCT EXPERIENCE.

    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 A MILDY CALCIFIED RIGHT FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE CLIP DID NOT DEPLOY. 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 67 YR Required Intervention