BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2904967 · Received January 9, 2013

    Report

    Report Number
    2024168-2013-00182
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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. IT IS INDICATED THAT THE DEVICE WAS DISCARDED AND IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES RELATED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT-HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE, ARTERIOTOMY CLOSURE WAS ATTEMPTED OF A MILDLY SCARRED COMMON FEMORAL ARTERY USING A STARCLOSE SE DEVICE. REPORTEDLY, DURING THUMB ADVANCER/EXCHANGE SHEATH SPLITTING, RESISTANCE WAS MET; ADDITIONAL FORCE WAS APPLIED COMPLETING DEPLOYMENT. THE STARCLOSE SE CLIP DEPLOYED SUCCESSFULLY ACHIEVING HEMOSTASIS. ALTHOUGH THE OPERATOR PERFORMED A NICK-AND-SPREAD INCISION PRIOR TO DEVICE INSERTION, THE ACCESS SITE SITE/GROIN WAS SCARRED, WHICH THE OPERATOR BELIEVED MAY HAVE BEEN A CONTRIBUTING FACTOR. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THE PHYSICIAN WAS REPORTED TO BE TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10861 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 21012K1

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR SHEATH: 6-FRENCHHEPARIN