BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2181844 · Received July 28, 2011

    Report

    Report Number
    2024168-2011-05336
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE NOTED THAT IT WAS PARTIALLY DEPLOYED. ALTHOUGH IT WAS REPORTED AFTER CLIP DEPLOYMENT, DIFFICULTY WAS ENCOUNTERED REMOVING THE DEVICE FROM THE PATIENT ANATOMY, THE CLIP-FIRING MECHANISM WAS NEVER ACTIVATED TO DEPLOY THE CLIP AND THERE WAS NO INDICATION THAT DIFFICULTY WAS ENCOUNTERED REMOVING THE DEVICE. ATTEMPTS TO OBTAIN CLARIFICATION WERE UNSUCCESSFUL. ANALYSIS OF THE DEVICE INDICATED, DURING DISTAL DEPLOYMENT OF THE THUMB ADVANCER, THE FLEX-GUIDE WAS CARVED INTO APPROXIMATELY ONE INCH FROM THE DISTAL-END OF THE CLIP DELIVERY TUBESET. THUMB ADVANCER DEPLOYMENT AND EXCHANGE SHEATH SPLITTING WERE UNABLE TO BE COMPLETED DUE TO RESISTANCE CAUSED BY FLEX-GUIDE CARVING. AS INDICATED IN THE STARCLOSE SE INSTRUCTIONS FOR USE, DEVICE DEPLOYMENT WAS ABORTED BY ACTIVATING THE SAFETY RELEASE TO COLLAPSE THE LOCATOR WINGS, WHICH ENABLED SAFE REMOVAL OF THE DEVICE FROM THE PATIENT ANATOMY. SUBSEQUENTLY, THE CLIP WAS NOT DEPLOYED IN THE VESSEL; THEREFORE, BLEEDING CONTINUED REQUIRING THE USE OF MANUAL ARTERIAL COMPRESSION TO ACHIEVE HEMOSTASIS AS REPORTED. CONTRIBUTING FACTORS FOR FLEX-GUIDE CARVING AT THE DISTAL END WHILE DEPLOYING THE THUMB ADVANCER INCLUDED, BUT ARE NOT LIMITED TO, MANUFACTURING DEFICIENCIES, CHALLENGING ANATOMICAL CONDITIONS, AND DEPLOYMENT TECHNIQUES; HOWEVER, THERE WERE NO CHALLENGING ANATOMICAL CONDITIONS REPORTED. A FAILURE TO MAINTAIN ALIGNMENT BETWEEN THE TUBESET AND FLEX-GUIDE THROUGHOUT THUMB ADVANCER DEPLOYMENT CAN CAUSE THE TUBESET TO CARVE INTO THE FLEX-GUIDE AS OBSERVED. THEREFORE, BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE CAUSE FOR THE FLEX-GUIDE CARVING AT THE DISTAL END IS INCORRECT DEVICE DEPLOYMENT TECHNIQUE. THE IFU, UNDER THE CLOSURE PROCEDURE SECTION, DESCRIBES THE THUMB ADVANCER DEPLOYMENT CLICK AS FOLLOWS: WHILE MAINTAINING APPOSITION OF THE LOCATOR WINGS ON THE ANTERIOR SURFACE OF THE ARTERIAL WALL AND KEEPING THE FLEX-GUIDE STRAIGHT, ADVANCE THE THUMB ADVANCER USING THE PAD OF THE RIGHT THUMB UNTIL THE NUMBER 3 APPEARS IN THE NUMBER WINDOW. THIS ADVANCES THE CLIP DELIVERY TUBE OVER THE FLEX-GUIDE WHILE SPLITTING THE SHEATH FROM THE HUB TO THE DISTAL TIP. AN AUDIBLE CLICK SHOULD BE HEARD. CHECK TO MAKE SURE THE NUMBER 3 IS COMPLETELY VISIBLE IN THE NUMBER WINDOW. THIS INDICATES THAT THE THUMB ADVANCER IS FULLY ADVANCED AND IN THE LOCKED POSITION. A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT DATABASE FOR THIS LOT REVEALED NO SIMILAR INCIDENTS. OVERALL, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. ADDITIONALLY, EVERY FLEX-GUIDE IS INSPECTED FOR PROPER ASSEMBLY DURING MANUFACTURING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DIAGNOSTIC CORONARY CATHERIZATION THROUGH A 6F PROCEDURE SHEATH, ARTERIOTOMY CLOSURE WAS ATTEMPTED OF THE COMMON FEMORAL ARTERY WITH A STARCLOSE SE DEVICE. REPORTEDLY, AFTER CLIP DEPLOYMENT, DIFFICULTY WAS ENCOUNTERED REMOVING THE DEVICE FROM THE TISSUE TRACT. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, THE DEVICE WAS REMOVED BY INSERTING A DILATOR INTO THE ACCESS PORTS THAT UNLOCKED AND ENABLED THE THUMB ADVANCER TO BE RETRACTED PROXIMALLY, WHICH ENABLED THE DEVICE TO BE WITHDRAWN FROM THE TISSUE TRACT. THE CLIP WAS DELIVERED APPROPRIATELY TO THE VESSEL AND ACHIEVED HEMOSTASIS; HOWEVER, THREE MINUTES OF ADJUNCTIVE COMPRESSION WAS APPLIED TO ADDRESS TISSUE TRACT OOZING. 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 050106H

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention PROCEDURAL SHEATH 6F