BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2212199 · Received August 15, 2011

    Report

    Report Number
    2024168-2011-05744
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 22, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE COMPLETED; HOWEVER, INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE RETURN OF THE DEVICE MAY HAVE ASSISTED THE INVESTIGATION OF THE COMPLAINT. THE CLIP MIGRATION TO THE SKIN SURFACE CAN OCCUR DUE TO DEPLOYMENT IN TISSUE OTHER THAN THE ARTERIAL TISSUE (MISLODGED/MISLOCATED CLIP). POSSIBLE CONTRIBUTING FACTORS TO A MISLODGED/MISLOCATED CLIP INCLUDE, MANUFACTURING, USER TECHNIQUE AND PATIENT ANATOMICAL CONDITIONS. DURING MANUFACTURING, ALL DEVICES ARE VISUALLY INSPECTED. A SAMPLING OF FINISHED DEVICES IS DESTRUCTIVELY TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. POSSIBLE CAUSES FOR THE REPORTED EXPERIENCE INCLUDE: INADEQUATE NICK AND SPREAD INCISION DURING PREPARATION OF THE ACCESS SITE, IMPROPER SEATING OF THE CLIP DELIVERY TUBE ON TOP OF THE ACCESS SITE, NOT MAINTAINING DOWNWARD PRESSURE AND DEVICE STABILITY WHILE DEPRESSING THE DEPLOYMENT BUTTON, INCORRECT ANGLE OF THE DEVICE DURING CLIP DEPLOYMENT (WHICH SHOULD BE 60-75 DEGREES)AND RETRACTION OF THE DEVICE DURING CLIP DEPLOYMENT. A REVIEW OF THE DEVICE HISTORY RECORD AND A QUERY OF THE COMPLAINT HANDLING DATABASE COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED AND THE DEVICE WAS NOT RETURNED. A CONCLUSIVE CAUSE TO THE REPORTED MIGRATION OF THE CLIP TO SKIN SURFACE, WHICH REQUIRED THE PATIENT TO UNDERGO THERAPY/NON-SURGICAL TREATMENT COULD BE DETERMINED. BASED ON THE REVIEW OF THE EVENT INFORMATION AND TESTING/INSPECTION CRITERIA FOR THIS DEVICE, A PRODUCT QUALITY DEFICIENCY WAS NOT NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY WAS ACHIEVED USING A STARCLOSE SE DEVICE AFTER A LONG LEG RUN-OFF PROCEDURE USING A 6F SHEATH. REPORTEDLY, AFTER A SUCCESSFUL CLOSURE OF THE GROIN ON (B)(6) 2011, THE PATIENT VISITED THE PHYSICIAN FOR THEIR INITIAL FOLLOW UP DURING THE WEEK OF (B)(6) 2011, WHEN IT WAS NOTICED THAT THE CLIP WAS VISIBLE ON THE SKIN LEVEL. THE CLIP WAS REMOVED THE SAME DAY WITHOUT SURGICAL INTERVENTION. THE PATIENT DID NOT EXPERIENCE ANY PHYSICAL DISCOMFORT OR PAIN. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. IT WAS ALSO REPORTED THAT THE TECHNICIAN IS TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention SHEATH: 6F