BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1980919 · Received February 7, 2011

    Report

    Report Number
    2024168-2011-00748
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    December 15, 2010
    Report Date
    January 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND IT WAS FULLY CLIP DEPLOYED. THE EXTERNAL COMPONENTS WERE IN THE CORRECT POST-DEPLOYED POSITIONS. ALTHOUGH THE EXCHANGE SHEATH WAS COMPLETELY SLIT, IT WAS ALSO TORN AT THE DISTAL-END. THE THUMB ADVANCER WAS LOCKED INTO THE STEP COMPLETION WINDOW INDICATING IT HAD NOT BEEN RETRACTED, WHICH IS CONSISTENT WITH AND CONFIRMS THE REPORTED PRODUCT EXPERIENCE. DURING INSPECTION OF THE INTERNAL COMPONENTS, THE LOCATOR WINGS WERE FOUND BENT, WHICH CAN INTERFERE WITH THEIR AUTOMATIC COLLAPSE DURING CLIP DEPLOYMENT. THE MOST PROBABLE ROOT CAUSE FOR THE BENT LOCATOR WINGS IS TISSUE BEING COMPRESSED BETWEEN THE CLIP DELIVERY TUBESET AND THE OPEN LOCATOR WINGS, WHICH CREATED DISTAL FORCE DURING THUMB ADVANCER DEPLOYMENT, BENDING THE LOCATOR WINGS, AND CREATING THE SUBSEQUENT RESISTANCE AND DIFFICULTY ENCOUNTERED DURING DEVICE REMOVAL. THE DAMAGED EXCHANGE SHEATH INDICATED THE DEVICE MIGHT HAVE BEEN TWISTED DURING THUMB AND ADVANCER DEPLOYMENT CAUSING THE TUBESET TO TEAR INTO THE EXCHANGE SHEATH. RESISTANCE ENCOUNTERED DURING THUMB ADVANCER DEPLOYMENT IS CONSISTENT WITH RADIAL FORCE CONSTRICTION ON THE EXCHANGE SHEATH. FACTORS THAT MAY ALSO CONTRIBUTE TO RADIAL FORCE CONSTRICTION MAY INCLUDE A TIGHT TISSUE TRACT OR OTHER ANATOMICAL CONDITIONS. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE ROOT CAUSE FOR THE BENT VESSEL LOCATOR WINGS AND TORN EXCHANGE SHEATH IS DUE TO USER TECHNIQUE AND THE OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS USED. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. A 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 WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    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, ALTHOUGH DURING THUMB ADVANCER DEPLOYMENT AND EXCHANGE SHEATH SPLITTING DIFFICULTY WAS ENCOUNTERED, CLIP DEPLOYMENT WAS COMPLETED. THE STARCLOSE SE DEVICE CLIP ACHIEVED HEMOSTASIS. ALTHOUGH, AFTER CLIP DEPLOYMENT, THE DEVICE WAS DIFFICULT TO REMOVE, THE DILATOR ASSISTED ACCESS PORTS OR THE SAFETY RELEASE DID NOT HAVE TO BE ACTIVATED. THE DEVICE WAS REMOVED FROM THE TISSUE TRACT WITH NON-SPECIFIC MANIPULATION. THE STARCLOSE SE DEVICE CLIP DEPLOYED IN THE INTENDED LOCATION AND SUCCESSFULLY ACHIEVED HEMOSTASIS. WHEN THE DEVICE WAS REMOVED, THE DISTAL END OF THE EXCHANGE SHEATH APPEARED TO BE DAMAGED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, 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-TEMECULA-CT 910216H

    Patients

    Seq Age Sex Outcome Treatment
    1