BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1902298 · Received November 11, 2010

    Report

    Report Number
    2953144-2010-02835
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 22, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN REC'D. INVESTIGATION IS NOT COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). THUMB ADVANCEMENT AGAINST RESISTANCE. EVALUATION OF THE RETURNED DEVICE FOUND IT WAS FULLY CLIP DEPLOYED. THE EXCHANGE SHEATH HAD BEEN TORN AND STRETCHED BEYOND THE DISTAL END OF THE TUBE SET CAPTURING THE CLIP DURING DEPLOYMENT. THE VESSEL LOCATOR WINGS WERE SEVERELY BENT. THE MOST PROBABLE ROOT CAUSE FOR THE BENT LOCATOR WINGS IS DUE TO TISSUE COMPRESSED BETWEEN THE TUBES AND OPEN LOCATORS. THIS CREATED DISTAL FORCE DURING THUMB ADVANCEMENT, BENDING THE LOCATOR WINGS AND CREATING THE DIFFICULT REMOVAL CONDITION. THE GARAGE LEAVES WERE BENT AND TWISTED FROM STRIKING AND CARVING INTO THE FLEX-GUIDE AND EXCHANGE SHEATH. THE MOST PROBABLE ROOT CAUSE FOR THIS TYPE OF DAMAGE IS DUE TO THE FLEX-GUIDE, TUBE SET AND TISSUE TRACT NOT BEING CORRECTLY ALIGNED DURING THUMB ADVANCEMENT. THIS MISALIGNMENT CAUSED THE SUPPORT TUBE TO STRIKE THE FLEX-GUIDE AND STOP, LEAVING THE GARAGE LEAVES UNSUPPORTED STRIKING AND CARVING INTO THE FLEX-GUIDE DURING THUMB ADVANCEMENT. SUBSEQUENTLY PREVENTING CLIP DEPLOYMENT. THE INSTRUCTIONS FOR USE (IFU) STATES: IN THE CLOSURE PROCEDURE SECTION, DO NOT ADVANCE THE THUMB ADVANCER AGAINST EXCESSIVE RESISTANCE. IF EXCESSIVE RESISTANCE IS EXPERIENCED DURING ADVANCEMENT OF THE THUMB ADVANCER, MANUALLY COLLAPSE THE LOCATOR WINGS AND REMOVE THE DEVICE. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THE REPORTED EVENT WAS RELATED TO INCORRECT TECHNIQUE OR PROCEDURE. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TECHNICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, RESISTANCE WAS MET 1-2 INCHES FROM COMPLETING STEP #3 (THUMB ADVANCEMENT) AND A LOT OF FORCE WAS NEEDED TO COMPLETE THE STEP. THE CLIP WAS DEPLOYED; HOWEVER, MANUAL COMPRESSION WAS APPLIED FOR AN ADDITIONAL 5-10 MINUTES TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PT SEQUELA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE WAS USED SEVERAL TIMES WITH NO ISSUES. THERE WAS A BLEEDER THAT THE SURGEON ATTEMPTED TO CLIP AND NO CLIP CAME OUT. THE CLIP WAS JAMMED SO THE SURGEON ATTEMPTED TO CLIP THE BLEEDER AGAIN AND NO CLIP CAME OUT. AN ENDO LOOP WAS USED TO CLIP THE BLEEDER AND TO COMPLETE THE PROCEDURE. THERE WAS APPROXIMATELY A MINIMAL AMOUNT OF BLOOD LOSS. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 920386H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention