BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2202884 · Received August 11, 2011

    Report

    Report Number
    2024168-2011-05682
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    March 31, 2011
    Report Date
    July 18, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND THAT IT WAS RETURNED PARTIALLY DEPLOYED. INSPECTION INDICATED THAT THE DISTAL END OF THE FLEX-GUIDE WAS HEAVILY CARVED BY THE DELIVERY TUBESET DURING THE THUMB ADVANCER DEPLOYMENT, RESULTING IN ONE OF THE GARAGE LEAVES BENT AND FOLDED INSIDE THE TUBESET. THE SHEATH WAS FULLY SLIT, BUT THE THUMB ADVANCER STROKE STOPPED SHORT OF COMPLETION, AS REPORTED, DUE TO RESISTANCE CAUSED BY FLEX-GUIDE CARVING. BECAUSE THE THUMB ADVANCER STROKE WAS NOT COMPLETE, THE CLIP-FIRING MECHANISM COULD NOT BE ACTIVATED TO FIRE THE CLIP OFF THE DELIVERY TUBESET WHEN DEPRESSING THE DEPLOYMENT BUTTON; THEREFORE, ARTERIOTOMY CLOSURE COULD NOT BE ACHIEVED AS REPORTED. INSPECTION REVEALED THAT THE SAFETY RELEASE WAS ACTIVATED TO DISENGAGE THE PLUNGER AND COLLAPSE THE VESSEL LOCATOR WINGS TO REMOVE THE DEVICE. HOWEVER, THE VESSEL LOCATOR WAS SEVERELY BENT, PREVENTING THE WINGS FROM COLLAPSING INTO THE TUBESET. FORCIBLY PULLING OUT THE DEVICE RESULTED IN ONE WING DETACHING FROM THE DISTAL RETAINING RING, BUT REMAINING SECURELY ATTACHED WITHIN THE LOCATOR, AS OBSERVED. DAMAGED WINGS WOULD RESULT IN DIFFICULT DEVICE REMOVAL; HOWEVER, THIS WAS NOT REPORTED. POSSIBLE CONTRIBUTING FACTORS FOR FLEX-GUIDE CARVING AT THE DISTAL END AND DAMAGED LOCATOR WINGS INCLUDED, BUT NOT LIMITED TO, MANUFACTURING DEFICIENCIES, CHALLENGING ANATOMICAL CONDITIONS, AND INCORRECT DEPLOYMENT TECHNIQUES. EVERY FLEX-GUIDE AND VESSEL LOCATOR IS INSPECTED FOR PROPER ASSEMBLY DURING MANUFACTURING, AND THE GARAGE TUBE LEAVES WERE INSPECTED DURING MANUFACTURING. FAILURE TO MAINTAIN ALIGNMENT BETWEEN THE TUBESET AND FLEX-GUIDE THROUGHOUT THE THUMB ADVANCER STROKE CAN CAUSE THE TUBESET TO CARVE INTO THE FLEX-GUIDE. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE CAUSE FOR THE FLEX-GUIDE CARVING IS INCORRECT DEPLOYMENT TECHNIQUE. ALTHOUGH THERE WAS NO CHALLENGING ANATOMICAL CONDITIONS REPORTED, BASED ON THE INVESTIGATION, THE PROBABLE CAUSE FOR THE DAMAGED LOCATOR WINGS (BENT AND BROKEN) 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. PER THE INSTRUCTIONS FOR USE (IFU), ADVANCE THE THUMB ADVANCER UNTIL THE NUMBER 3 ENTERS THE WINDOW. THIS ADVANCES THE CLIP DELIVERY TUBE OVER THE FLEX-GUIDE WHILE SPLITTING THE SHEATH FROM THE HUB TO THE DISTAL TIP. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY RELEVANT NONCONFORMING MATERIAL RECORDS FOR THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT.

    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 REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT STATES: AFTER THE CLIP WAS FIRED, HEMOSTASIS WAS NOT ACHIEVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE DEVICE AFTER AN INTERVENTIONAL PROCEDURE USING A 6F SHEATH. REPORTEDLY, THE CLIP NOT DEPLOY. IT IS UNKNOWN IF THE ACCESS PORTS AND THE SAFETY RELEASE BUTTON WERE USED. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. IT WAS REPORTED THAT THE PHYSICIAN IS TRAINED IN THE USE OF THE STARCLOSE SE DEVICE. 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 960226H

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention SHEATH: 6F