BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1920430 · Received December 10, 2010

    Report

    Report Number
    2953144-2010-03199
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 18, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION OF THE RETURNED DEVICE FOUND THAT THE DISTAL END OF THE DEVICE APPEARED NORMAL AND THE EXCHANGE SHEATH WAS FULLY SLIT. THE THUMB ADVANCER WAS AT THE FINISH POSITION, INDICATING THAT THE ACCESS PORTS WERE NOT USED. DURING CLIP DEPLOYMENT, THE VESSEL LOCATOR WINGS ARE DESIGNED TO AUTOMATICALLY COLLAPSE SO AS NOT TO INTERFERE WITH THE CLIP DEPLOYMENT. HOWEVER, DURING THE INSPECTION OF THE DEVICE, THE VESSEL LOCATOR WINGS WERE FOUND BENT. THE BENT LOCATOR WINGS INDICATE THAT DISTAL FORCES WERE APPLIED TO THE WINGS DURING THUMB ADVANCEMENT, PREVENTING THEM FROM COLLAPSING PROXIMALLY INTO THE TUBESET. TISSUE COMPRESSED BETWEEN THE DISTAL END OF THE TUBES AND BEHIND THE OPEN VESSEL LOCATOR WINGS DURING THUMB ADVANCEMENT IS THE MOST PROBABLE CAUSE FOR THE BENT LOCATOR WINGS AND IT SUBSEQUENTLY CONTRIBUTED TO DIFFICULT DEVICE REMOVAL. THE DEVICE WAS CLEANED AND RE-ASSEMBLED FOR RE-DEPLOYMENT ATTEMPT AND THE RESULT WAS SUCCESSFUL AS DESIGNED. REPORTEDLY, THE PHYSICIAN WAS NOT TRAINED AND THIS IS NOT CONSISTENT WITH THE STARCLOSE INSTRUCTIONS FOR USE (IFU). BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE ROOT CAUSE FOR THE BENT WINGS IS RELATED TO THE OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS USED. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE INITIALLY REPORTED AS DISCARDED, BUT HAS RETURNED. (B)(4). THE PROBLEM DURING THE CASE WAS: STARCLOSE DEVICE WAS USED TO ACHIEVE HEMOSTASIS OF THE RIGHT GROIN. AFTER FIRING THE STARCLOSE DEVICE, MARKED RESISTANCE TO REMOVE OF THE DEVICE, WHOLLY ATYPICAL FROM THE USUAL FUNCTION IN THIS DEVICE WHICH THE USER HAD EXPERIENCED IN HIS PRIOR FREQUENT USE OF THE DEVICE. THE DEVICE WAS REMOVED AND THE USER OBSERVED MARKED BLEEDING FROM THE PUNCTURE SITE DESPITE MANUAL COMPRESSION. WITH MARKED MANUAL COMPRESSION WAS ABLE TO ACHIEVE A RELATIVE DEGREE OF HEMOSTASIS BUT HAD TO CALL A SURGEON AND IMMEDIATELY TAKE THE PATIENT TO THE OPERATING ROOM FOR EXPLORATORY SURGERY. ADDITIONAL INFORMATION RECEIVED FROM THE ACCOUNT INDICATED THAT HEMOSTASIS WAS SURGICALLY ACHIEVED.

    Additional Manufacturer Narrative · 1

    (B)(4). OPERATOR NOT TRAINED. THE DEVICE WAS NOT RETURNED. A PROBABLE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, A USER FACILITY MEDWATCH WAS RECEIVED WITH THE FOLLOWING INFORMATION. EVENT DESC: PATIENT HAD LEFT PERIRENAL HEMATOMA WHICH WAS SUSPECTED TO BE A LEFT PSEUDOANEURYSM OF THE KIDNEY SO UNDERWENT THE FOLLOWING PROCEDURES: ABDOMINAL AORTOGRAPHY, MAIN RENAL ARTERY CATHETERIZATION AND ANGIOGRAPHY. STARCLOSE GROIN CLOSURE RIGHT SIDE. DESCRIPTION OF PROCEDURE: RIGHT GROIN WAS PREPPED AND DRAPED IN STERILE FASHION. RIGHT COMMON FEMORAL ARTERY PERTAINS TO PUNCTURE. A GUIDE WIRE IS THREADED THROUGH THE NEEDLE, NEEDLE REMOVED AND A 5-FRENCH SHEATH ADVANCED INTO RIGHT EXTERNAL ILIAC ARTERY AND THE FLUOROSCOPY. PIGTAIL CATHETER IS RESENT THE ABDOMINAL AORTA AND ABDOMINAL AORTOGRAPHY PERFORMED. COBRA CATHETER WAS ADVANCED INTO THE MAIN LEFT RENAL ARTERY AND ANGIOGRAPHY WAS PERFORMED IN TWO PROJECTIONS. CATHETER WAS THEN EXCHANGED FOR MICROCATHETER WAS ADVANCE INTO 5 SEPARATE DISTAL THIRD ORDER A SUPER ELECTIVE BRANCHES OF THE RENAL ARTERY AND MAGNIFICATION MULTI-PROJECTION RENAL ANGIOGRAPHY WAS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN NOT TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, AFTER THE CLIP WAS DEPLOYED, THE DEVICE WAS STUCK. THE METHOD USED TO REMOVE THE DEVICE WAS NOT SPECIFIED; HOWEVER, THE PATIENT WAS TAKEN TO THE OPERATING ROOM DUE TO BLEEDING. NO DISSECTION WAS FOUND AND THE METHOD USE TO ACHIEVED HEMOSTASIS WAS NOT REPORTED. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-REDWOOD CITY 930016H

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention