BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2040284 · Received April 5, 2011

    Report

    Report Number
    2024168-2011-02384
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 16, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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 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: EVALUATION OF THE RETURNED DEVICE FOUND IT WAS FULLY CLIP-DEPLOYED. THE RETURNED CONDITION REVEALED THAT THUMB ADVANCER STROKE AND SHEATH SPLIT WERE COMPLETE WITHOUT ANY DAMAGES. INSPECTION OF THE RETURNED DEVICE SUGGESTED THAT THE LOCATOR WINGS WERE INITIALLY BENT DURING THUMB ADVANCER DEPLOYMENT DUE TO TISSUE COMPACTION THAT EXERTED A DISTAL FORCE ON THE WINGS, PREVENTING THE WINGS FROM FULLY COLLAPSING INTO THE DELIVERY TUBESET WHEN THE CLIP WAS FIRED. THE FAILURE OF THE WINGS TO COMPLETELY COLLAPSE INTO THE DELIVERY TUBESET DIRECTLY RESULTED IN DIFFICULT DEVICE REMOVAL. ONE OF THE WINGS WAS DETACHED FROM THE DISTAL RETAINING RING DUE TO COUNTER-TRACTION AND ASSERTIVE PULL, BUT REMAINED SECURELY ATTACHED WITHIN THE LOCATOR. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE ROOT CAUSE FOR THE DAMAGED LOCATOR WINGS (BENT AND BROKEN) THAT DIRECTLY RESULTED IN THE REPORTED DIFFICULT DEVICE REMOVAL IS TISSUE COMPACTION THAT EXERTED A DISTAL FORCE ON THE WINGS WHILE IN THE TISSUE TRACT. TISSUE TRAPPED BETWEEN THE DISTAL END OF THE TUBESET AND THE LOCATOR WINGS CAN BEND AND EVENTUALLY BREAK THE WINGS DURING REMOVAL. DAMAGED LOCATOR WINGS COULD INTERFERE WITH THE CLIP DEPLOYMENT AND DEVICE REMOVAL. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    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 FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, RESISTANCE WAS FELT WHILE ADVANCING THE THUMB ADVANCER TO SPLIT THE SHEATH. THE CLIP WAS DEPLOYED; HOWEVER, THE DEVICE COULD NOT BE REMOVED. THE PROCEDURE WAS PROLONGED 45 TO 60 MINUTES. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, THE ACCESS PORTS WERE USED TO SUCCESSFULLY FACILITATE DEVICE REMOVAL. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. 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 870426H

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention