BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2202646 · Received August 11, 2011

    Report

    Report Number
    2024168-2011-05677
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 20, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE RETURN OF THE DEVICE MAY HAVE ASSISTED THE INVESTIGATION OF THE COMPLAINT. A CLIP CATCHING THE BACK WALL (MISLOCATED CLIP) CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, MANUFACTURING, USER TECHNIQUE AND, PATIENT ANATOMICAL CONDITIONS. DURING MANUFACTURING, ALL DEVICES ARE VISUALLY INSPECTED. IN ADDITION A SAMPLING OF FINISHED DEVICES IS DESTRUCTIVELY TESTED TO VERIFY THE FUNCTIONALITY OF THE DEVICE. INADEQUATE NICK AND SPREAD INCISION, 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 WITH THE RIGHT THUMB, INCORRECT ANGLE OF THE DEVICE DURING CLIP DEPLOYMENT, WHICH SHOULD BE 60-75 DEGREES, AND RETRACTION OF THE DEVICE DURING CLIP DEPLOYMENT MAY CAUSE THE CLIP TO BECOME MISLOCATED. PATIENT ANATOMICAL CONDITIONS(E.G. HEAVILY CALCIFIED ARTERIES, MORBIDLY OBESE PATIENTS, ETC.) MAY ALSO CONTRIBUTE TO THE REPORTED EXPERIENCE; HOWEVER, RELEVANT PATIENT MEDICAL HISTORY WAS NOT PROVIDED. A CONCLUSIVE CAUSE FOR THE REPORTED CLIP CATCHING THE BACK WALL OF THE ARTERY CAUSING AN OCCLUSION, WHICH RESULTED IN PAIN, SURGICAL PROCEDURE AND CAUSED THE PATIENT TO BE HOSPITALIZED, COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE LOT HISTORY RECORD AND A QUERY OF THE COMPLAINT-HANDLING DATABASE WERE NOT PERFORMED BECAUSE THE DEVICE LOT NUMBER WAS NOT REPORTED. BASED ON THE REVIEW OF THE EVENT INFORMATION AND TESTING/INSPECTION CRITERIA FOR THIS DEVICE, A PRODUCT QUALITY DEFICIENCY WAS NOT DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE DEVICE AFTER A NEURO INTERVENTIONAL PROCEDURE (TUMOR EMBOLIZATION). REPORTEDLY, UPON DEVICE DEPLOYMENT, THE CLIP CAUGHT THE BACK WALL OF THE ARTERY. AFTER THE ARTERIOTOMY CLOSURE, THE PATIENT COMPLAINED OF PAIN AND A COLD LEG. AN ULTRASOUND WAS TAKEN SHOWING SIGNIFICANT NARROWING IN THE AREA OF THE ARTERY. THE CLIP WAS EXTRACTED SURGICALLY AND THE SITE WAS CLOSED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TWO DAYS LATER ((B)(4) 2011). THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. IT WAS REPORTED THAT THE PHYSICIAN 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 Hospitalization| R SHEATH: 6F