BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2250892 · Received September 16, 2011

    Report

    Report Number
    2024168-2011-06343
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 26, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE RETURNED STARCLOSE SE DEVICE WAS RECEIVED FULLY CLIP DEPLOYED AND THE DEPLOYED CLIP WAS NOT LOCATED ON THE DISTAL END OF THE DEVICE, NOR WAS THE CLIP RETURNED. ALL EXTERNAL OBSERVATIONS INDICATED THE DEVICE COMPONENTS WERE IN THEIR PROPER POST CLIP DEPLOYED POSITIONS. AT THE DISTAL END OF THE DEVICE, THE VESSEL LOCATOR WAS RETRACTED INTO THE DISTAL END OF THE CLIP DELIVERY TUBE AND ALL FOUR VESSEL LOCATOR WINGS (VLW) WERE NOTED TO BE MISSING FROM VIEW. INTERNAL INSPECTION OF THE DEVICE DID NOT PRESENT ANY HANDLE COMPONENT ANOMALY. INSPECTION OF THE VESSEL LOCATOR ASSEMBLY DETERMINED ALL FOUR VLW WERE BROKEN. ALL BROKEN WING MATERIAL HAD BEEN RETURNED AND ALL FOUR VLW ATTACHMENT POINTS WITHIN THE VESSEL LOCATOR ASSEMBLY WERE SECURE. BECAUSE THE REPORTED CAPTURE OF THE CLIP ON THE DISTAL END OF THE DEVICE WAS NOT OBSERVED, IT WAS NOT POSSIBLE TO CONFIRM THE REPORTED COMPLAINT. THE REPORTED CAPTURED CLIP MAY HAVE BECOME DISLODGED POST PROCEDURE AT SOME POINT DURING ITS HANDLING. BROKEN VLW CAN BE CAUSED BY NUMEROUS FACTORS, INCLUDING BUT NOT LIMITED, TO MANUFACTURING, MATERIALS, TECHNIQUE/PROCEDURAL AND/OR ANATOMY. ANATOMICALLY, THE PATIENT WAS REPORTED TO HAVE HAD PRIOR ARTERIOTOMY CLOSURE AT THE TARGET GROIN. SCAR TISSUE MAY HAVE BEEN PRESENT WHICH MAY HAVE PLAYED A ROLE IN THE PERFORMANCE OF THE DEVICE DURING CLIP DEPLOYMENT AND VLW COLLAPSE CAUSING THE DEPLOYED CLIP TO BE CAPTURED ON THE RETRACTING VLW. THE STARCLOSE SE INSTRUCTIONS FOR USE STATES TO CONSIDER BLUNT DISSECTION BY SINGLE SPREAD WITH SURGICAL INSTRUMENT IN THE SKIN INCISION, ESPECIALLY IN THOSE PATIENTS WITH SCAR TISSUE. PROCEDURALLY, DISTAL DIRECTIONAL FORCES CAN BE APPLIED TO THE DEPLOYED VLW FROM TISSUE COMPACTION BETWEEN THE CLIP DELIVERY TUBES DISTAL END AND DEPLOYED VLW DURING THE DEPLOYMENT OF THE THUMB ADVANCER/DELIVERY TUBE SET THROUGH THE TISSUE TRACT, POSSIBLY BE DUE TO AN INSUFFICIENT NICK AND SPREAD. THIS CONDITION MAY ALSO INHIBIT CORRECT VLW RETRACTION INTO THE DISTAL END OF THE DELIVERY TUBE AFTER CLIP DEPLOYMENT, BENDING AND IN SOME CASES CAUSING BREAKAGE OF THE VLW, WHICH MAY ALSO CAPTURE A DEPLOYED CLIP. HOWEVER, THERE WAS NO REPORT OF DIFFICULT INSERTION OR ADVANCEMENT OF THE DEVICE INDICATING THE NICK AND SPREAD WAS LIKELY SUFFICIENT. DURING MANUFACTURING, ALL VESSEL LOCATOR ASSEMBLIES ARE INSPECTED DURING THE MANUFACTURING PROCESS TO ASSURE PROPER ASSEMBLY AND OPERATION. ADDITIONALLY, A SAMPLING OF COMPLETED STARCLOSE SE UNITS FROM THE LOT IS FUNCTIONALLY AND DESTRUCTIVELY TESTED TO VERIFY PROPER DEVICE OPERATION AND NO FAILURE WAS DETECTED. A REVIEW OF THE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT-HANDLING DATABASE FOR THIS LOT INDICATED THERE HAVE BEEN NO OTHER PREVIOUS INCIDENTS REPORTED FOR THE DEPLOYED CLIP CAPTURED ON THE DISTAL END OF THE DEVICE. BASED ON THE RETURNED PRODUCT EVALUATION, THERE WAS NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCY AND THE CAUSE FOR THE DAMAGED CONDITION OF THE DEVICE WAS RELATED TO OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY WAS ATTEMPTED USING THE STARCLOSE SE DEVICE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER THE STARCLOSE SE CLIP WAS DEPLOYED, THE CLIP WAS FOUND AT THE END OF THE DEVICE. MANUAL ARTERIAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA. THE TECHNICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE DEVICE. 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 060096H

    Patients

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