BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2170586 · Received July 21, 2011

    Report

    Report Number
    2024168-2011-05059
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

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

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED STARCLOSE SE DEVICE REVEALED THAT THE DEVICE WAS FULLY CLIP-DEPLOYED. THREE OF THE FOUR LOCATOR WINGS WERE BENT AND ONE WAS BROKEN. HOWEVER, ALL FOUR LOCATOR WINGS REMAINED SECURELY ATTACHED WITHIN THE LOCATOR WING ASSEMBLY. ALTHOUGH, THE EXCHANGE SHEATH WAS COMPLETELY SPLIT, IT WAS STRETCHED AT DISTAL-END, WHICH CAUSED THE CLIP TINES TO PUNCTURE INTO THE EXCHANGE SHEATH DURING CLIP DEPLOYMENT. SUBSEQUENTLY, THE CLIP WAS CAPTURED WITHIN THE EXCHANGE SHEATH INSTEAD OF BEING FULLY DELIVERED TO THE ARTERIAL SURFACE TO CLOSE THE VESSEL. ARTERIAL BLEEDING WOULD CONTINUE DUE TO THE CLIP BEING CAPTURED IN THE EXCHANGE SHEATH INSTEAD OF THE VESSEL, WHICH WOULD REQUIRE AN ALTERNATIVE METHOD TO ACHIEVE HEMOSTASIS. MANUFACTURING DEFICIENCIES, ANATOMICAL CONDITIONS, AND DEPLOYMENT TECHNIQUE CAN CONTRIBUTE TO THE LOCATOR WINGS AND EXCHANGE SHEATH DAMAGE; HOWEVER, THERE WERE NO SUCH ISSUES REPORTED. BASED ON THE EVALUATION, THE PROBABLE CAUSE FOR THE BENT AND BROKEN LOCATOR WINGS IS TISSUE COMPACTION THAT EXERTED A DISTAL FORCE ON THE LOCATOR WINGS WHILE IN THE TISSUE TRACT. TISSUE TRAPPED BETWEEN THE DISTAL-END OF THE CLIP DELIVERY TUBESET AND THE LOCATOR WINGS CAN BEND AND BREAK THE LOCATOR WINGS, INTERFERE WITH THE CLIP DEPLOYMENT, AND CAUSE DIFFICULTY REMOVING THE DEVICE. THE PROBABLE CAUSE FOR THE STRETCHED EXCHANGE SHEATH THAT CAPTURED THE CLIP IS A TIGHT TISSUE TRACT. INSTEAD OF THE CLIP DELIVERY TUBESET SLIDING EASILY WITHIN THE EXCHANGE SHEATH, TISSUE COMPRESSION FORCES CAN CAUSE THE EXCHANGE SHEATH TO DRAG ALONG WITH THE CLIP DELIVERY TUBESET AS IT IS DISTALLY ADVANCED. SUBSEQUENTLY, THE EXCHANGE SHEATH ELONGATES WHICH CAN CAUSE INTERFERENCE WITH CLIP DEPLOYMENT. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. IN ADDITION, A QUERY OF THE COMPLAINT DATABASE FOR THIS LOT REVEALED NO PRODUCT EXPERIENCES, WHICH THE DEPLOYED CLIP WAS CAPTURED AT THE DISTAL-END OF THE EXCHANGE SHEATH. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO A 100% INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DIAGNOSTIC PERIPHERAL CATHERIZATION THROUGH A 6F PROCEDURAL SHEATH, ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED WITH A STARCLOSE SE DEVICE. REPORTEDLY, AFTER CLIP DEPLOYMENT, BLEEDING CONTINUED. MANUAL ARTERIAL COMPRESSION WAS APPLIED FOR FIVE MINUTES TO ACHIEVE HEMOSTASIS. A REVIEW OF THE DEVICE REVEALED THAT, ALTHOUGH RESISTANCE DURING DEPLOYMENT WAS NOT FELT, THE EXCHANGE SHEATH DID NOT SPLIT COMPLETELY, AND THE CLIP DEPLOYED IN THE EXCHANGE SHEATH. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. 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 050076H

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention BRITE TIP SHORT SHEATH 6F