BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1222535 · Received November 6, 2008

    Report

    Report Number
    2953144-2008-01787
    Event Type
    Injury
    Date Received
    November 6, 2008
    Date of Event
    February 27, 2006
    Report Date
    October 15, 2008
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. TIME OF MALFUNCTION: AFTER VESSEL CLOSURE. SYMPTOMS/AE: RIGHT LEG PAIN. IT WAS REPORTED THAT AFTER UNEVENTFUL ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY IN 2006, WITH THE STARCLOSE DEVICE, CONSTANT RIGHT LEG PAIN DEVELOPED FROM THE GROIN TO BEHIND THE KNEE. THE SITE HAS NO SWELLING OR DISCOLORATION BUT IS SENSITIVE TO PRESSURE THAT CAUSES THE PAIN TO INTENSIFY. MEDICATION HAS NOT REDUCED OR RESOLVED THE PAIN. A DOPPLER ULTRASOUND REVEALED THE ARTERY IS OF GOOD SIZE, THE CLIP WAS DEPLOYED IN THE PROPER LOCATION, AND WAS NOT DEPLOYED IN A NERVE. A MEDICAL RECOMMENDATION WAS MADE TO MAKE AN INCISION IN THE SUBCUTANEOUS TISSUE AT THE CLOSURE SITE TO RELEASE PRESSURE DUE TO SCAR TISSUE. THE PATIENT DECLINED AND DECIDED TO CONSULT WITH ANOTHER VASCULAR SURGEON, WHICH HAS YET TO BE COMPLETE. SHOULD INTERVENTION BE PERFORMED A FOLLOW-UP REPORT WILL BE SUBMITTED THROUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: ALTHOUGH THE SYMPTOMS OF THE PATIENT ARE UNCHANGED AND ONGOING, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT HAS CONSULTED A PAIN MANAGEMENT PHYSICIAN THAT BELIEVES THE STARCLOSE DEVICE CLIP IS ATTACHED TO A NERVE NEXT TO THE COMMON FEMORAL ARTERY. THE PHYSICIAN REFUSED TO SURGICALLY REMOVE THE CLIP, PRESCRIBED A TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) UNIT, AND A NON-SPECIFIC ANTIPSYCHOTIC MEDICATION FOR PAIN MANAGEMENT. HOWEVER, THE PATIENT REFUSES TO USE THE TENS UNIT AND WILL NOT TAKE THE PRESCRIBED MEDICATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK