BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 3901029 · Received June 30, 2014

    Report

    Report Number
    2024168-2014-04197
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INITIAL MEDWATCH REPORT WAS FILED WITH THE ADVERSE EVENT, REQUIRING INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE BOXES CHECKED. MEDICAL ASSESSMENT CONFIRMED NO ADVERSE PATIENT EFFECTS OCCURRED AND NO MEDICAL OR SURGICAL INTERVENTION WAS PERFORMED. REPORTED EVENT IS A MALFUNCTION ONLY. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED INABILITY TO ENGAGE THE HUB WITH THE SHEATH. AS PART OF THE INVESTIGATION, A REVIEW OF THE ELECTRONIC LOT HISTORY RECORD (ELHR) FOR THE REPORTED LOT WAS PERFORMED AND REVEALED NO NONCONFORMING MATERIAL RECORDS (NCMRS) THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE MOST PROBABLE CAUSE OF THE INABILITY TO ENGAGE THE SHEATH AND HUB MAY BE DUE TO MISALIGNMENT OF THE SHEATH RELATIVE TO THE CLIP APPLIER. THE POTENTIAL MISALIGNMENT DOES NOT RESULT FROM A PRODUCT DEFICIENCY. THESE DEVICES ARE TESTED DURING MANUFACTURING AND PASSED ALL LOT RELEASE TESTING, CONFIRMING NO PRODUCT DEFICIENCY IS SUSPECTED. THIS TYPE OF REPORTED COMPLAINT WILL CONTINUE TO BE MONITORED PER LOCAL QUALITY PROCEDURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE DEVICE WITH A 5F SHEATH AFTER A NEUROLOGICAL INTERVENTIONAL PROCEDURE. REPORTEDLY, THE SHEATH WOULD NOT CLICK INTO THE HUB. TO USE THE DEVICE THE SHEATH AND HUB WERE HELD TOGETHER MANUALLY. HEMOSTASIS WAS ACHIEVED WITH THE CLIP. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. THE PHYSICIAN IS REPORTEDLY 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
    380602 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 40317K1

    Patients

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