BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2240194 · Received September 9, 2011

    Report

    Report Number
    2024168-2011-06217
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 15, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE FOUND IT PARTIALLY DEPLOYED WITH THE SHEATH ATTACHED. THE DEVICE PLUNGER WAS IN THE DEPLOYED POSITION WITH SUBSEQUENT AND PROPER VESSEL LOCATOR WING (VLW) DEPLOYMENT AND PARTIAL THUMB ADVANCER/DELIVERY TUBESET DEPLOYMENT WITH PARTIAL SLITTING OF THE SHEATH, AS EXPECTED. EXAMINATION OF THE VESSEL LOCATOR DID NOT DETECT ANY DAMAGE OR ANOMALY NORMALLY ASSOCIATED WITH DEVICE REMOVAL FROM THE ANATOMY WITH THE VLW DEPLOYED. INTERNAL COMPONENT INSPECTION DID NOT DETECT ANY ANOMALY AND ALL COMPONENTS WERE IN THEIR PROPER POSITIONS FOR THE RECEIVED STATE OF THE DEVICE. THE DEVICE WAS RESET FOR REDEPLOYMENT TESTING AND THE TESTING WAS SUCCESSFUL WITH NO DETECTED ANOMALY. INADVERTENT DEVICE REMOVAL FROM THE ANATOMY WITH THE VLW DEPLOYED MAY BE CAUSED BY DIFFERENT FACTORS. IT IS POSSIBLE, AFTER THE PLUNGER WAS DEPLOYED TO DEPLOY THE VLW AND THE DEVICE WAS RETRACTED TO POSITION THE VLW AGAINST THE INNER ARTERIAL WALL SURFACE, THAT EXCESSIVE FORCE MAY HAVE BEEN APPLIED TO POSITION THE DEVICE AGAINST THE ARTERY WALL, INADVERTENTLY PULLING THE DEVICE OUT OF THE ARTERY. THIS WOULD NORMALLY LEAVE THE VLW BENT; HOWEVER, THE VLW DID NOT PRESENT ANY OBSERVATION TO SUPPORT THIS. ANOTHER POSSIBLE FACTOR IS, BASED ON THE UNDAMAGED CONDITION OF THE VLW, IS THAT ONCE THE EXCHANGE SHEATH WAS PLACED WITHIN THE ARTERIOTOMY AND THE GUIDE WIRE IS REMOVED, THE STARCLOSE SE DEVICE IS THEN INSERTED INTO THE PROXIMAL END OF THE SHEATH THROUGH THE SHEATH HUB. DURING THIS STEP, IT IS POSSIBLE THAT THE SHEATH MAY HAVE BEEN INADVERTENTLY REPOSITIONED PROXIMALLY TOWARD THE STARCLOSE SE DEVICE TO FACILITATE SHEATH TO STARCLOSE SE DEVICE ATTACHMENT, PULLING THE SHEATH FROM THE ARTERIOTOMY WITH THE SHEATH THEN RESTING WITHIN ONLY THE SUBCUTANEOUS TISSUE AND NOT WITHIN THE ARTERY. ONCE THE STARCLOSE SE DEVICE IS ATTACHED TO THE SHEATH, THE VLW IS DEPLOYED AND THE DEVICE IS RETRACTED TO LOCATE THE ARTERIAL WALL. THE DEVICE WOULD PULL OUT OF THE ANATOMY DUE TO A LACK OF RESISTANCE FROM THE LOSS OF ARTERIAL ACCESS. THE PROBABLE CAUSE FOR THE REPORTED EVENT IS LIKELY RELATED TO THE OPERATIONAL CONTEXT IN THE USE OF THE DEVICE AND NOT A PRODUCT QUALITY DEFICIENCY. ALL VESSEL LOCATOR ASSEMBLIES ARE INSPECTED DURING THE MANUFACTURING PROCESS TO HELP ENSURE PROPER ASSEMBLY AND OPERATION. A SAMPLING OF UNITS FROM THE LOT IS FUNCTIONALLY AND DESTRUCTIVELY TESTED TO VERIFY PROPER DEVICE OPERATION AND NO FAILURE WAS DETECTED. REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. A QUERY OF THE COMPLAINT-HANDLING DATABASE FOR THIS LOT INDICATED THERE HAVE BEEN NO OTHER SIMILAR INCIDENTS REPORTED FOR A LOSS OF ARTERIAL ACCESS. BASED ON THE INVESTIGATION, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    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

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF A NON-CALCIFIED RIGHT COMMON FEMORAL ARTERY (RCFA) AFTER A DIAGNOSTIC HEART CATH PROCEDURE USING THE STARCLOSE SE DEVICE. REPORTEDLY, AFTER DEPLOYING THE VESSEL LOCATOR WINGS, THE PHYSICIAN RETRACTED THE DEVICE TO POSITION IT AGAINST THE ARTERIAL WALL AND THE DEVICE CAME OUT OF THE ARTERY. MANUAL ARTERIAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO ADVERSE PATIENT EFFECTS. A 5FR SHEATH WAS USED DURING THE PROCEDURE. 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 060526H

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention SHEATH: 5 FR.