BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1851788 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02217
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    November 16, 2009
    Report Date
    November 30, 2009
    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). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THE LOCATOR WINGS WERE INITIALLY BENT DURING THUMB ADVANCER DEPLOYMENT AND PREVENTED THE WINGS FROM FULLY COLLAPSING INTO THE DELIVERY TUBESET WHEN THE CLIP WAS DEPLOYED. THE FAILURE OF THE WINGS TO COMPLETELY COLLAPSE INTO THE DELIVERY TUBESET DIRECTLY RESULTED IN DIFFICULT DEVICE REMOVAL. THE THUMB ADVANCER AND DELIVERY TUBESET WERE RETRACTED BY USE OF THE ACCESS PORTS. COUNTER-TRACTION AND ASSERTIVE PULL WOULD DETACH THE WINGS FROM THE DISTAL RETAINING RINGS AS OBSERVED. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE ROOT CAUSE FOR THE DAMAGED LOCATOR WINGS (BENT AND BROKEN) IS TISSUE COMPACTION THAT EXERTED A DISTAL FORCE ON THE WINGS WHILE IN THE TISSUE TRACT. TISSUE TRAPPED BETWEEN THE DISTAL END OF THE TUBESET AND THE LOCATOR WINGS CAN BEND THE WINGS AND EVENTUALLY BREAK THEM DURING FORCEFUL REMOVAL. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TECH TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE IN THE RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT THE DEVICE WAS DIFFICULT TO REMOVE FROM THE PT ARTERY. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, AN ATTEMPT WAS MADE TO USE THE ACCESS PORTS, HOWEVER, IT WAS UNSUCCESSFUL. THE DEVICE WAS ULTIMATELY REMOVED USING COUNTER-TRACTION AND ASSERTIVE PULL. HEMOSTASIS WAS ACHIEVED WITH THE CLIP AND MANUAL COMPRESSION FOR THREE MINS. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 82032-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention