BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1878249 · Received October 18, 2010

    Report

    Report Number
    2953144-2010-02516
    Event Type
    Injury
    Date Received
    October 18, 2010
    Date of Event
    September 6, 2010
    Report Date
    September 23, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THE DEVICE WAS PARTIALLY FULLY DEPLOYED. THE DEVICE WAS RETURNED WITH THE CLIP AT THE DISTAL END OF DEVICE ON THE FLEX-GUIDE. THE SHEATH SLITTING WAS INCOMPLETE. THE THUMB ADVANCER HAD BEEN UNLOCKED VIA THE ACCESS PORTS AND RETRACTED AS FAR PROXIMAL AS POSSIBLE. THIS FINDING INDICATES THAT RESISTANCE WAS ENCOUNTERED DURING DEPLOYMENT ALTHOUGH NOT REPORTED. THE DEVICE WAS OPENED TO EXAMINE THE INTERNAL COMPONENTS AND THEY WERE FOUND IN THE CORRESPONDING RETRACTED POSITIONS AND UNDAMAGED WITH THE EXCEPTION OF THE GARAGE BLOCK. THE MOVEMENT OF AN INTERNAL COMPONENT (GARAGE BLOCK) WAS RESTRICTED WHICH RESULTED IN THE PROXIMAL DISPLACEMENT OF THE COMPONENTS TUBE AND EXPOSURE OF THE LOADED CLIP. THIS PREVENTED FURTHER DEPLOYMENT OF THE DEVICE AND THE CLIP BY LIMITING THE MOVEMENT OF THE CLIP PUSHER BLOCK/TUBE ASSEMBLY. THE PUSHER BLOCK DID NOT CONNECT WITH A COMPONENT AT THE DISTAL END OF THE RELEASE ROD TO COLLAPSE THE LOCATOR WINGS AND DISENGAGE THE PLUNGER DUE TO THE RESTRICTED MOVEMENT OF THE GARAGE BLOCK. THE ROOT CAUSE FOR THE RESTRICTED MOVEMENT OF THE GARAGE BLOCK AND SUBSEQUENT INABILITY TO DEPLOY THE CLIP IS DUE TO RESISTANCE ENCOUNTERED WHILE ADVANCING THE THUMB ADVANCER. RESISTANCE ENCOUNTERED DURING THUMB ADVANCER DEPLOYMENT IS CONSISTENT WITH RADIAL FORCE CONSTRICTION ON THE SHEATH. FACTORS THAT MAY CONTRIBUTE TO RADIAL FORCE CONSTRICTION MAY INCLUDE A TIGHT TISSUE TRACT OR ANATOMICAL CONDITIONS. THE INVESTIGATION IS ON-GOING. A 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 PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE SHEATH COULD NOT BE COMPLETELY SPLIT. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER THAT ONE (1) CE INTERMATE LV100 DEVICE WAS OBSERVED WITH THE LUER LOCK TIP BROKEN OFF DURING SHIPMENT TO THE PATIENT'S HOME. ACCORDING TO THE REPORT, THE DEVICE WAS FILLED WITH 200ML OF VANCOMYCIN (12.5MG/ML IN NORMAL SALINE). THE CUSTOMER STATED THERE IS SOME TUBING STILL EXTENDING PAST THE SLIDE CLAMP FROM WHERE THE LUER LOCK BROKE OFF AND DOES NOT BELIEVE THE SLIDE CLAMP CAUSED THIS. THE PHARMACIST STATED SHE DOES NOT HAVE THE MISSING PIECE AND THAT THE DEVICE WAS NOT CONNECTED TO THE PATIENT (NO PATIENT INVOLVEMENT). NO ADDITIONAL INFORMATION IS AVAILABLE.

    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 900296H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention