BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2060279 · Received April 15, 2011

    Report

    Report Number
    2024168-2011-02677
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 ADDITIONAL RELEVANT INFORMATION

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND THE DEVICE WAS FULLY CLIP DEPLOYED WITH ALL EXTERNAL AND INTERNAL COMPONENTS IN THE APPROPRIATE POST CLIP DEPLOYMENT POSITION, EXCEPT THAT THE SAFETY RELEASE BUTTON WAS DISLOCATED; HOWEVER, A DISLOCATED SAFETY RELEASE BUTTON WAS CONSISTENT WITH POST-PROCEDURE MANIPULATION RATHER THAN A DEVICE FAILURE AS NOTHING WAS DETECTED THAT MIGHT HAVE CAUSED DIFFICULTY IN REMOVING THE DEVICE AFTER CLIP DEPLOYMENT. THE RETURNED DEVICE INDICATED THAT IT WAS FULLY FUNCTIONAL AS INTENDED. THE THUMB ADVANCER STROKE AND SHEATH SLIT WERE COMPLETE. THERE WERE NO DAMAGES TO THE SHEATH TO SUGGEST THAT RESISTANCE MIGHT HAVE BEEN ENCOUNTERED DURING THE THUMB ADVANCER DEPLOYMENT AND SHEATH SPLITTING PROCESS. THE CLIP WAS SUCCESSFULLY FIRED OFF THE DEVICE AND THE LOCATOR WINGS WERE FULLY COLLAPSED AS DESIGNED. AN INADEQUATE NICK AND SPREAD AND OTHER CHALLENGING ANATOMICAL CONDITIONS CAN ALSO BE CONTRIBUTING FACTORS, BUT THESE COULD NOT BE CONFIRMED. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. BASED ON THE INVESTIGATION FINDINGS, A ROOT CAUSE RELATED TO THE DEVICE COULD NOT BE DETERMINED. THE DEVICE PERFORMED ACCORDING TO SPECIFICATION. A REVIEW OF THE PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. 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 THE RIGHT COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, ALTHOUGH DURING THUMB ADVANCER DEPLOYMENT MORE RESISTANCE THAN USUAL WAS NOTED, DEPLOYMENT WAS COMPLETED AND THE STARCLOSE SE DEVICE CLIP ACHIEVED HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. 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 010206H

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention SHEATH: INTRODUCTOR 5F