BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2251441 · Received September 16, 2011

    Report

    Report Number
    2024168-2011-06362
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    June 30, 2011
    Report Date
    August 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 AND THE RETURNED CONDITION SUBSTANTIATED THE REPORTED DIFFICULT DEVICE REMOVAL AFTER THE CLIP DEPLOYMENT. INSPECTION OF THE DEVICE SUGGESTED THAT THE LOCATOR WINGS WERE INITIALLY BENT DURING THE THUMB ADVANCER DEPLOYMENT, PREVENTING THE WINGS FROM FULLY COLLAPSING INTO THE DELIVERY TUBESET WHEN THE CLIP WAS FIRED. THE FAILURE OF THE WINGS TO COMPLETELY COLLAPSE INTO THE DELIVERY TUBESET DIRECTLY RESULTED IN DIFFICULT DEVICE REMOVAL AS REPORTED. ALTHOUGH NOT REPORTED, IT WAS FOUND THAT THE ACCESS PORTS AND SAFETY RELEASE WERE NOT UTILIZED TO FACILITATE THE DEVICE REMOVAL. FORCIBLY PULLING OUT THE DEVICE WOULD RESULT IN THE VESSEL LOCATOR WINGS DETACHING AT THE DISTAL RETAINING RING AS OBSERVED. HOWEVER, ALL BROKEN WINGS REMAINED SECURELY ATTACHED WITHIN THE LOCATOR. THE INSTRUCTIONS FOR USE (IFU) STATES THAT IF RESISTANCE IS MET UPON REMOVAL OF THE DEVICE, FOLLOW THE STEPS IN THE IFU. THE IFU ALSO STATES TO PERFORM A FEMORAL ANGIOGRAM TO VERIFY THE LOCATION OF THE PUNCTURE SITE. POSSIBLE CONTRIBUTING FACTORS FOR BROKEN VESSEL LOCATOR WINGS INCLUDE, BUT ARE NOT LIMITED TO MANUFACTURING, CHALLENGING ANATOMICAL CONDITIONS, AND/OR INCORRECT DEPLOYMENT TECHNIQUE. EVERY VESSEL LOCATOR WING ASSEMBLY WAS INSPECTED AND TESTED FOR PROPER ASSEMBLY DURING MANUFACTURING. THERE WERE NO CHALLENGING ANATOMICAL CONDITIONS REPORTED, WHICH COULD HAVE CONTRIBUTED TO BROKEN WINGS. THERE WAS NO INFORMATION REPORTED OR DEFINITIVE EVIDENCE IN THE EVALUATION OF THE RETURNED DEVICE TO SUGGEST THAT THE DEVICE WAS INCORRECTLY DEPLOYED, WHICH COULD HAVE CONTRIBUTED TO BROKEN WINGS. BASED ON THE MANUFACTURING INSPECTION CRITERIA AND ANALYSIS OF THE RETURNED DEVICE, THE PROBABLE CAUSE FOR THE DAMAGED LOCATOR WINGS (BENT AND BROKEN) THAT DIRECTLY RESULTED IN THE REPORTED DIFFICULT DEVICE REMOVAL 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 BEND THE WINGS AND EVENTUALLY BREAK THEM DURING FORCEFUL REMOVAL. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THIS LOT WAS PERFORMED AND THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT PRODUCT QUALITY DEFICIENCY.

    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. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE DEVICE AFTER A HEPATIC CHEMOEMBOLIZATION PROCEDURE. REPORTEDLY, AFTER CLIP DEPLOYMENT, STRONG RESISTANCE WAS EXPERIENCED DURING DEVICE REMOVAL. AFTER SOME MANIPULATION AND THE USE OF THE DEVICE'S RELEASE MECHANISM, THE DEVICE WAS REMOVED AND MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. ON DEVICE REMOVAL, A MATERIAL FRACTURE WAS OBSERVED TO HAVE OCCURRED ON THE DEVICE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. IT WAS REPORTED THAT THE PHYSICIAN IS TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. 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 850476H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6F