BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2212207 · Received August 15, 2011

    Report

    Report Number
    2024168-2011-05745
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 22, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. DEVICE CODE 2017: OPERATOR NOT TRAINED AND FAILURE TO FOLLOW STEPS (FEMORAL ANGIOGRAM NOT TAKEN). 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE RETURNED DEVICE WAS RECEIVED PARTIALLY DEPLOYED AND IN THE SAFETY RELEASE ACTIVATED STATE. THE PLUNGER AND VESSEL LOCATOR WINGS (VLW) RETRACTED; HOWEVER, THE ACCESS PORT FUNCTION WAS NOT ACTIVATED AS REPORTED. THE THUMB ADVANCER/DELIVERY TUBESET WAS PARTIALLY DEPLOYED, THE SHEATH WAS PARTIALLY SLITTING WITH THE SLIT TERMINATING APPROXIMATELY AT THE TERMINATION POINT OF THE DISTAL END OF THE DELIVERY TUBE. THE FLEX GUIDE AND THE DISTAL END OF THE DELIVERY TUBE WERE BENT. THE SHEATH WAS REMOVED FROM THE DISTAL END OF THE DEVICE AND SHAFT CARVING OF THE FLEX GUIDE WAS NOTED TO BE LOCATED AT THE DISTAL END OF THE DELIVERY TUBE. INTERNAL INSPECTION DID NOT DETECT ANY ANOMALY TO RESTRICT THE USE OF THE ACCESS PORT MECHANISM. THE OBSERVED FLEX GUIDE SHAFT CARVING WOULD HAVE STOPPED THE DISTAL DEPLOYMENT OF THE THUMB ADVANCER AND POSITION OF THE THUMB ADVANCER/DELIVERY TUBESET, CONFIRMING THE REPORTED JAMMED CONDITION OF THE DEVICE. THE RETRACTED POSITIONS OF THE PLUNGER AND VLW CONFIRM THE REPORTED USE OF THE SAFETY RELEASE MECHANISM TO RETRACT THE VLW; HOWEVER, THE REPORTED USE OF THE ACCESS PORT MECHANISM WAS NOT CONFIRMED. THE DETECTED FLEX-GUIDE CARVING AND THE RESULTING COMPONENT DAMAGE AND THE BENT FLEX GUIDE, IS CONSISTENT WITH A FAILURE TO MAINTAIN THE ALIGNMENT OF THE CLIP DELIVERY COMPONENTS WHILE THE THUMB ADVANCER IS DISTALLY DEPLOYED, WHICH IS AN ERROR IN USER TECHNIQUE. THIS RESULTS IN THE DISTAL END OF THE DELIVERY TUBE CARVING INTO THE FLEX-GUIDE OUTER NYLON MATERIAL STOPPING THE DISTAL DEPLOYMENT OF THE THUMB ADVANCER/DELIVERY TUBESET. THE STARCLOSE SE INSTRUCTIONS FOR USE (IFU) STATES: 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. REPORTEDLY, THE PATIENT HAS A HISTORY OF PERIPHERAL VASCULAR DISEASE, WHICH MAY HAVE PLAYED A ROLE IN THE EVENT. THERE WERE NO OTHER OBSERVATIONS FOR THIS EVENT. THE REPORTED USE OF THE DEVICE BY AN UNTRAINED PHYSICIAN IS OFF-LABEL USE. THE IFU STATES: THIS DEVICE IS RESTRICTED TO SALE BY OR ON THE ORDER OF PHYSICIANS WHO HAVE BEEN TRAINED BY AN AUTHORIZED REPRESENTATIVE OF ABBOTT VASCULAR. PRIOR TO USE, THE OPERATORS MUST REVIEW THE INSTRUCTIONS FOR USE AND BE FAMILIAR WITH THE DEPLOYMENT TECHNIQUES ASSOCIATED WITH THE USE OF THIS DEVICE. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. A QUERY OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. TO ASSURE THERE IS NO DEFECT RELATED TO THE THUMB ADVANCER/DELIVERY TUBE DEPLOYMENT, THE LOT IS VISUALLY INSPECTED FOR PROPER THUMB ADVANCER MOVEMENT AND FOR DEFECTS TO THE FLEX GUIDE. ADDITIONALLY, TO ASSURE THE DEVICES MEET SPECIFICATION, A SAMPLING OF THE LOT IS FUNCTIONALLY AND DESTRUCTIVELY TESTED AND THE LOT PASSED TESTING WITH NO DETECTED FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE DEVICE AFTER A FEMORAL ANGIOPLASTY INTERVENTIONAL PROCEDURE USING A 6F SHEATH. REPORTEDLY, DURING THUMB ADVANCEMENT (STEP 3), THE DEVICE 'JAMMED'. PER THE INSTRUCTIONS FOR USE, THE ACCESS PORTS AND SAFETY RELEASE BUTTON WERE USED AND THE DEVICE WAS THEN REMOVED. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. IT WAS REPORTED THAT THE PHYSICIAN IS NOT 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 040206H

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention SHEATH: 6F