BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1933511 · Received December 20, 2010

    Report

    Report Number
    2953144-2010-03295
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    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). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE DETECTED A PARTIALLY DEPLOYED DEVICE WITH AN INCOMPLETELY INSTALLED EXCHANGE SHEATH. THE SHEATH HUB WAS NOT FULLY SEATED AND WAS LOCKED INTO THE HANDLE OF THE DEVICE. THIS PREVENTED THE DISTAL MOVEMENT OF THE SHEATH ASSEMBLY WHEN THE PLUNGER/THUMB ADVANCER WAS DEPLOYED. THE INITIAL SLIT IN THE SHEATH HAD BEEN GENERATED BY THE CUTTER, INDICATING THAT THE CUTTER DID MAKE CONTACT WITH THE SHEATH. THE INCOMPLETE INSTALLATION OF THE HUB INTO THE HANDLE CAUSED THE SHEATH TO MOVE DISTALLY WITH THE DEPLOYING DELIVERY TUBE SET, NOT PERMITTING THE SLIT TO PROPAGATE. INSPECTION OF THE DEVICE AND EXCHANGE SHEATH DID NOT DETECT ANY DEVICE ANOMALY THAT MAY HAVE CONTRIBUTED TO THE INCOMPLETE INSTALLATION OF THE SHEATH HUB. DURING DEVICE TESTING, AN ATTEMPT WAS MADE TO FULLY INSTALL THE EXCHANGE SHEATH ONTO THE STARCLOSE SE DEVICE. THE ATTEMPT WAS SUCCESSFUL WITH A DISTINCTIVE CLICK HEARD, INDICATING FULL HUB SEATING HAD OCCURRED IN THE HANDLE OF THE DEVICE. NO OTHER OBSERVATIONS WERE NOTED. BASED ON THE INVESTIGATION FINDINGS THERE WAS NO DETECTED MANUFACTURING OR QUALITY ISSUE AND THE CAUSE FOR THE INCOMPLETELY INSTALLED EXCHANGE SHEATH COULD NOT BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4):DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    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 A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE SHEATH WOULDN'T SPLIT. THE DEVICE WAS REMOVED AND MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. 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-REDWOOD CITY 940026H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention