BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1972153 · Received January 27, 2011

    Report

    Report Number
    2024168-2011-00501
    Event Type
    Injury
    Date Received
    January 27, 2011
    Date of Event
    November 9, 2010
    Report Date
    December 1, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OPERATOR NOT TRAINED. EVALUATION OF THE RETURNED DEVICE FOUND IT WAS FULLY CLIP DEPLOYED WITH BLOOD PRESENT THROUGHOUT THE DEVICE INDICATING INSERTION INTO THE PATIENTS ANATOMY. THIS FINDING IS NOT CONSISTENT WITH THE REPORT OF VESSEL LOCATOR WINGS DEPLOYED OUTSIDE THE PATIENT. THE THUMB ADVANCE WAS LOCKED IN THE #3 POSITION AND WAS NOT RETRACTED AND THE VESSEL LOCATOR WINGS WERE BENT. THE MOST PROBABLE CAUSE FOR THE BENT LOCATOR WINGS IS DUE TO TISSUE COMPRESSED BETWEEN THE DISTAL END OF THE TUBE AND BEHIND THE OPEN LOCATORS CREATING DISTAL FORCES DURING THUMB ADVANCEMENT BENDING THE LOCATOR WINGS. THE EXCHANGE SHEATH WAS COMPLETELY SLIT WITH OBSERVED CLIP TINE PUNCTURE MARKS BUT HAD ALSO BEEN STRETCHED BEYOND THE DISTAL END OF THE TUBE SET DURING THUMB ADVANCEMENT CAPTURING THE CLIP DURING DEPLOYMENT. A POSSIBLE CAUSE FOR THE EXCHANGE SHEATH STRETCHING IS A TIGHT TISSUE TRACT. INSTEAD OF THE TUBE SET SLIDING EASILY WITHIN THE SHEATH, TISSUE COMPRESSION FORCES MAY CAUSE THE SHEATH TO DRAG ALONG WITH THE TUBE SET AS IT IS DISTALLY ADVANCED. SUBSEQUENTLY, THE SHEATH ELONGATES WHICH CAN CAUSE INTERFERENCE WITH CLIP DEPLOYMENT. BASED ON THE INVESTIGATION, THE MOST PROBABLE ROOT CAUSE FOR THE STRETCHED SHEATH AND THE SUBSEQUENT CLIP CAPTURED IN THE DISTAL END OF THE EXCHANGE SHEATH IS RELATED TO INCORRECT TECHNIQUE/PROCEDURE OPERATIONAL CONTEXT WHERE THE DEVICE WAS USED. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD FORT HIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS INVESTIGATION. (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN, NOT TRAINED IN THE USE OF THE STARCLOSE SE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE PHYSICIAN WAS WORKING QUICKLY AND DEPLOYED THE LOCATOR WINGS WHILE THE DEVICE WAS OUTSIDE THE PATIENT. THE DEVICE DID NOT HAVE CONTACT WITH THE PATIENT AND WAS NOT USED; THE PHYSICIAN CHOSE TO USE MANUAL COMPRESSION TO ACHIEVE HEMOSTASIS. MANUAL COMPRESSION WAS APPLIED FOR APPROXIMATELY 45 MINUTES. THERE WAS NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED. HOWEVER, ANALYSIS OF THE RETURNED DEVICE FOUND BLOOD THROUGHOUT THE DEVICE INDICATING IT WAS INSERTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 720286H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ANGIOMAX