BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1894986 · Received November 5, 2010

    Report

    Report Number
    2953144-2010-02726
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 14, 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
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: INVESTIGATION OF THE RETURNED DEVICE FOUND THAT IT WAS FULLY CLIP DEPLOYED. THE THUMB ADVANCER HAD BEEN UNLOCKED AND RETRACTED AS FAR PROXIMAL AS POSSIBLE. THIS FINDING IS CONSISTENT AND CONFIRMS THE REPORTED EXPERIENCE OF DIFFICULT REMOVAL. THE DISTAL TIP OF THE SHEATH WAS RUFFLED FROM BEING STRETCHED BEYOND THE DISTAL END OF THE TUBESET AND STRIKING THE OPENED VESSEL LOCATOR WINGS DURING DEPLOYMENT. THE TIP WAS ALSO TORN BY THE CLIP TINES DURING CLIP DEPLOYMENT. THE DAMAGE DETECTED WITH THE EXCHANGE SHEATH IS WITH RADIAL FORCE CONSTRICTION ON THE SHEATH CAUSING IT TO ELONGATE AND INTERFERE WITH CLIP DEPLOYMENT. FACTORS THAT MAY CONTRIBUTE TO RADIAL FORCE CONSTRICTION MAY INCLUDE A TIGHT TISSUE TRACT OR ANATOMICAL CONDITIONS. DURING CLIP DEPLOYMENT THE VESSEL LOCATORS ARE DESIGNED TO AUTOMATICALLY COLLAPSE SO AS NOT TO INTERFERE WITH THE CLIP DEPLOYMENT. HOWEVER, THE VESSEL LOCATOR WINGS OF THIS DEVICE WERE BENT. THE MOST PROBABLE ROOT CAUSE FOR THE BENT LOCATOR WINGS IS DUE TO TISSUE COMPRESSED BETWEEN THE TUBES AND OPEN LOCATORS. THIS CREATED DISTAL FORCE DURING THUMB ADVANCEMENT, BENDING THE LOCATOR WINGS AND CREATING THE DIFFICULT REMOVAL CONDITION. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE FOR THE DAMAGE DETECTED FOR THE DIFFICULT REMOVAL ARE RELATED TO THE OPERATIONAL CONTEXT DURING USE OF THE DEVICE. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 DURING A DA VINCI S URETEROPLASTY PROCEDURE, THE CUSTOMER EXPERIENCED SYSTEM ERROR CODE 23017. WITH THE ASSISTANCE OF A TECHNICAL SUPPORT ENGINEER (TSE), THE SITE PERFORMED AN EMERGENCY POWER OFF (EPO) TO RESTART THE SYSTEM MULTIPLES TIMES, HOWEVER, SYSTEM ERROR RECURRED. THE SURGEON DECIDED TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE. NO PATIENT HARM WAS REPORTED.

    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 A DIAGNOSTIC PROCEDURE. REPORTEDLY, AN ATTEMPT WAS MADE TO DEPLOY THE CLIP, BUT THE VESSEL LOCATOR WINGS OF THE STARCLOSE SE DEVICE DID NOT RETRACT. THE DEVICE COULD NOT BE REMOVED. AS PER THE INSTRUCTIONS FOR USE, THE ACCESS PORTS AND SAFETY RELEASE BUTTON WERE USED REMOVING IT FROM THE ANATOMY. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO 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 ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 920406H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention