BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1946359 · Received January 4, 2011

    Report

    Report Number
    2024168-2011-00009
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND IT WAS FULLY CLIP-DEPLOYED; HOWEVER, THE CLIP DID NOT ACHIEVE HEMOSTASIS AND WAS RETURNED OUTSIDE THE DEVICE. THE RETURNED CONDITION SUBSTANTIATED THE REPORTED EXPERIENCE. INSPECTION OF THE RETURNED DEVICE INDICATED THAT THE LOCATOR WINGS WERE BENT DURING THUMB ADVANCER DEPLOYMENT, PREVENTING THE WINGS FROM FULLY COLLAPSING INTO THE DELIVERY TUBESET WHEN THE CLIP WAS FIRED. ALSO, THE SHEATH WAS STRETCHED AND ITS DISTAL END WAS PUNCTURED BY THE CLIP TINES. BENT LOCATOR WINGS COMBINED WITH STRETCHED SHEATH THAT CAPTURED THE CLIP WOULD RESULT IN DIFFICULT DEVICE REMOVAL. BASED ON THE INVESTIGATION, THE PROBABLE CAUSE FOR THE BENT LOCATOR WINGS 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 DAMAGE THE WINGS WHEN ACTIVATING THE CLIP-FIRING MECHANISM. THE PROBABLE CAUSE FOR THE STRETCHED SHEATH THAT CAPTURED THE CLIP IS TIGHT TISSUE TRACT. INSTEAD OF THE TUBESET SLIDING EASILY WITHIN THE SHEATH, TISSUE COMPRESSION FORCES MAY CAUSE THE SHEATH TO DRAG ALONG WITH THE TUBESET AS IT IS DISTALLY ADVANCED, RESULTING IN THE SHEATH BEING ELONGATED AND PUNCTURED BY THE CLIP TINES. BENT WINGS AND STRETCHED SHEATH COULD INTERFERE WITH THE CLIP DEPLOYMENT AND DEVICE REMOVAL. NO MANUFACTURING OR QUALITY ISSUE WAS DETECTED. 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 IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN IN TRAINING IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT AND REMOVAL OF THE DEVICE FROM THE ANATOMY, HEMOSTASIS WAS NOT ACHIEVED. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. AFTER THE PROCEDURE, THE DEVICE WAS INSPECTED AND IT WAS OBSERVED THAT THE CLIP WAS ON THE DISTAL END OF THE DEVICE. THERE WAS NO REPORTED 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 AV-TEMECULA-CT 830416H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention