BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1904988 · Received November 22, 2010

    Report

    Report Number
    2953144-2010-02918
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 27, 2010
    Manufacturer
    AV-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION OF THE RETURNED DEVICE FOUND THAT IT WAS FULLY CLIP-DEPLOYED AS INDICATED BY PROPERLY DISPLACED CATCH AND CLIP TINE MARKS ON THE CARRIER TUBE. INSPECTION REVEALED BENT LOCATOR WINGS, PREVENTING THEM FROM FULLY COLLAPSING INTO THE DELIVERY TUBESET WHEN THE CLIP WAS FIRED. THE FAILURE OF THE WINGS TO COMPLETELY COLLAPSE INTO THE DELIVERY TUBESET DIRECTLY RESULTED IN THE DIFFICULTLY DURING DEVICE REMOVAL AS REPORTED. THE PLUNGER WAS FOUND FULLY FUNCTIONAL. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE ROOT CAUSE FOR THE BENT LOCATOR WINGS THAT DIRECTLY RESULTED IN THE REPORTED DIFFICULT DEVICE REMOVAL IS TISSUE COMPACTION THAT EXERTED A DISTAL FORCE ON THE WINGS DURING THUMB ADVANCER DEPLOYMENT. TISSUE TRAPPED BETWEEN THE DISTAL END OF THE TUBESET AND THE LOCATOR WINGS CAN BEND THE WINGS AND INTERFERE WITH THE CLIP DEPLOYMENT. 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

    DURING TROUBLESHOOTING A LOW DRAIN VOLUME ALARM APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING INITIAL DRAIN, THE HOME PATIENT (HP)'S CAREGIVER (CG) REVEALED THAT THERE WAS AIR IN PATIENT LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CG TO END THERAPY AND ADVISED TO START OVER WITH NEW SUPPLIES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL 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 AN UNSPECIFIED ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE PLUNGER COULD NOT BE PRESSED TO COMPLETION AND BECAME STUCK. PER THE INSTRUCTIONS FOR USE, AN ATTEMPT TO USE THE SAFETY RELEASE PORT WAS MADE TO HELP RELEASE THE DEVICE FROM THE ARTERY WITHOUT SUCCESS. THE DEVICE WAS THEN PULLED AND REMOVED FROM THE ANATOMY. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. REPORTEDLY, A FEMORAL ANGIOGRAM WAS NOT TAKEN BEFORE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA. 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 900216H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention