BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1892698 · Received November 3, 2010

    Report

    Report Number
    2953144-2010-02711
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    ABBOTT VASCULAR-REDWOOD CITY
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE FOUND BROKEN VESSEL LOCATOR WINGS, WHICH IS CONSISTENT WITH DIFFICULT TO REMOVE DEVICE EVENTS AND CONFIRMS THE REPORTED EVENT. THE DEVICE DID DISPLAY PROPERLY DEPLOYED SAFETY RELEASE AND ACCESS PORT RETRACTION SYSTEMS, INDICATING AN ATTEMPT HAD BEEN MADE TO REMOVE THE DEVICE ACCORDING TO THE INSTRUCTIONS FOR USE. A POSSIBLE, THOUGH UNCONFIRMED CAUSE FOR THE DAMAGED WING CONDITION, MAY BE RELATED TO THE OPERATIONAL CONTEXT IN THE USE OF THE DEVICE, EITHER PROCEDURAL OR ANATOMICAL. PROCEDURALLY, DISTAL PRESSURE CAN BE APPLIED TO THE DEPLOYED LOCATOR WINGS DURING THE DEPLOYMENT OF THE CLIP DELIVERY TUBESET THROUGH A TIGHT TISSUE TRACT, POSSIBLY FROM AN INSUFFICIENT NICK AND SPREAD. THIS CAN COMPACT TISSUE BETWEEN THE LOCATOR WINGS AND THE DISTAL END OF THE CLIP DELIVERY TUBE, PUSHING THE DEPLOYED LOCATOR WINGS DISTALLY AWAY FROM THE OPERATOR. THIS CONDITION CAN INHIBIT CORRECT LOCATOR WING RETRACTION INTO THE DISTAL END OF THE DELIVERY TUBE AFTER CLIP DEPLOYMENT, DAMAGING THE WINGS. ANATOMICALLY, ANY FEATURE WITHIN THE BODY SUCH AS, SCAR TISSUE OR CALCIFICATION MAY PREVENT CORRECT LOCATOR WING RETRACTION. HOWEVER, NO ANATOMICAL INFORMATION WAS PROVIDED. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THE DAMAGED VESSEL LOCATOR WINGS IS RELATED TO THE OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS USED. 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 FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, THERE WAS DIFFICULTY IN WITHDRAWING THE DEVICE FROM THE ANATOMY. AS PER THE INSTRUCTIONS FOR USE, THE ACCESS PORTS AND SAFETY RELEASE BUTTON WERE USED WITH NO SUCCESS AND THE DEVICE WAS PULLED OUT OF THE ANATOMY. UPON REMOVAL, IT WAS OBSERVED THAT THE VESSEL LOCATOR WINGS DID NOT RETRACT, ONE WING APPEARED TO BE BROKEN, BUT THERE WAS NO MATERIAL MISSING. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANTERIOR AND POSTERIOR PELVIC FLOOR REPAIR PROCEDURE ON (B)(6) 2009. ON (B)(6) 2010, THE PATIENT CAME TO THIS HOSPITAL BECAUSE SHE WAS EXPERIENCING PAINFUL INTERCOURSE. THE DOCTOR FOUND THAT THERE WAS MESH IN THE URINARY BLADDER AND VAGINA AND SHE HAD A VESICOVAGINAL FISTULA. IT IS PLANNED THAT THE PATIENT WILL UNDERGO REPAIR OF VESICOVAGINAL FISTULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB ABBOTT VASCULAR-REDWOOD CITY NA 860116H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention