BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2162373 · Received July 14, 2011

    Report

    Report Number
    2024168-2011-04961
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 17, 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. 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. IT WAS REPORTED THAT SCAR TISSUE AT THE GROIN SITE MIGHT HAVE PLAYED A ROLE IN THE PRODUCT EXPERIENCE. THE INSTRUCTIONS FOR USE STATE UNDER CLOSURE PROCEDURE STEP #1. IT IS NECESSARY TO CREATE A 5-7 MM SKIN INCISION AT THE SHEATH SITE TO ACCOMMODATE THE INSERTION OF THE CLIP DELIVERY TUBE INTO THE TISSUE TRACT. THIS SHOULD BE DONE AT THE BEGINNING OF THE PROCEDURE PRIOR TO THE ADMINISTRATION OF ANTICOAGULANTS AND ANTIPLATELET AGENTS, IF POSSIBLE. CONSIDER BLUNT DISSECTION BY SINGLE SPREAD WITH SURGICAL INSTRUMENT IN THE SKIN INCISION, ESPECIALLY PATIENTS WITH SCAR TISSUE FROM PREVIOUS CATHERIZATIONS PROCEDURES. FAILURE TO ADEQUATELY PERFORM A NICK-N-SPREAD WILL CAUSE RESISTANCE BETWEEN THE CLIP DELIVERY TUBESET, EXCHANGE SHEATH, AND TISSUE TRACT DURING DEPLOYMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED STARCLOSE SE DEVICE REVEALED THAT IT WAS PARTIALLY DEPLOYED. THUMB ADVANCER DEPLOYMENT WAS COMPLETED AND REMAINED IN THE FINISHED POSITION. THE LOCATOR WINGS HAD BEEN COLLAPSED INTO THE TUBESET. THESE FINDING ARE CONSISTENT WITH THE REPORTED USE OF THE SAFETY RELEASE TO MANUALLY COLLAPSE THE LOCATOR WINGS BEFORE DEVICE REMOVAL. THE LEAVES OF THE GARAGE TUBE WERE BENT AND TWISTED, WHICH DAMAGED THE EXCHANGE SHEATH BY TEARING INTO THE TUBING AND CARVING INTO THE NYLON FLEX-GUIDE DURING DISTAL DEPLOYMENT OF THE THUMB ADVANCER. FLEX-GUIDE CARVING STARTED APPROXIMATELY 2 CM DISTAL OF THE STRAIN RELIEF, WHICH INDICATES THAT THE DAMAGE OCCURRED DURING PLUNGER DEPLOYMENT. THE STARTING LOCATION OF THE FLEX-GUIDE CARVING INDICATES THAT DISTAL DEPLOYMENT OF THE THUMB ADVANCER WAS CONTINUED AFTER RESISTANCE WAS ENCOUNTERED DURING PLUNGER DEPLOYMENT. THIS TYPE OF DAMAGE OCCURS WHEN THE FLEX-GUIDE, THE TUBESET, AND TISSUE TRACT ARE NOT CORRECTLY ALIGNED DURING DEPLOYMENT OF THE THUMB ADVANCER. THIS MISALIGNMENT CAUSED THE SUPPORT TUBE TO STOP AND STRIKE THE FLEX-GUIDE LEAVING THE LEAVES OF THE GARAGE TUBE UNSUPPORTED, STRIKING, AND CARVING INTO THE FLEX-GUIDE AND EXCHANGE SHEATH DURING THUMB ADVANCER DEPLOYMENT, WHICH SUBSEQUENTLY PREVENTING CLIP DEPLOYMENT. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU) STATE TO PLACE THE LEFT HAND ON THE STABILIZER TO STABILIZE THE DEVICE AT THE ANGLE OF THE TISSUE TRACK. DEPLOY THE LOCATOR WINGS AND INITIATE SPLITTING OF THE EXCHANGE SHEATH SAYS THAT THE DEVICE IS TO BE STABILIZED AT THE ANGLE OF THE TISSUE TRACT DURING PLUNGER DEPLOYMENT. UNDER THE CLOSURE PROCEDURE, THE IFU STATES WHILE MAINTAINING APPOSITION OF THE LOCATOR WINGS ON THE ANTERIOR SURFACE OF THE ARTERIAL WALL TO KEEP THE FLEX-GUIDE STRAIGHT ADVANCE THE THUMB ADVANCER USING THE PAD OF THE RIGHT THUMB UNTIL THE NUMBER THREE APPEARS IN THE COMPLETION WINDOW. ALTHOUGH NOT REPORTED THIS TYPE OF DAMAGE GENERALLY CREATES EXCESSIVE RESISTANCE AS THUMB ADVANCER DEPLOYMENT IS CONTINUED, WHICH THE IFU STATES DO NOT ADVANCE THE THUMB ADVANCER AGAINST EXCESSIVE RESISTANCE. IF EXCESSIVE RESISTANCE IS EXPERIENCED DURING THUMB ADVANCER DEPLOYMENT, THE OPERATOR IS INSTRUCTED TO MANUALLY COLLAPSE THE LOCATOR WINGS AND REMOVE THE DEVICE; THE LOCATOR WINGS WERE MANUALLY COLLAPSED. NYLON SHAFT CARVING CAN BE CAUSED BY, BUT NOT LIMITED TO, A FAILURE TO MAINTAIN KEEP THE FLEX-GUIDE STRAIGHT DURING THE PLUNGER AND THUMB ADVANCER DEPLOYMENT. IT WAS REPORTED THAT SCARRING WAS PRESENT AT THE ACCESS SITE, WHICH MAY HAVE BEEN A CONTRIBUTING FACTOR. DEVICE DEPLOYMENT IN CHALLENGING ANATOMIES SUCH AS HEAVY CALCIFIED ARTERIES, SCARRING, AND MORBIDLY OBESE PATIENTS CAN CONTRIBUTE TO THIS TYPE OF PRODUCT EXPERIENCE. FLEX-GUIDE CARVING PREVENTED CLIP DEPLOYMENT TO CLOSE THE ACCESS SITE; THEREFORE, BLEEDING CONTINUED REQUIRING MANUAL COMPRESSION TO ACHIEVE HEMOSTASIS. A REVIEW OF THE LOT HISTORY RECORD WAS PERFORMED AND THERE WERE NO RELEVANT NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS LOT. THE CARVING OF THE FLEX-GUIDE PREVENTED DELIVERY OF THE CLIP TO CLOSE THE ACCESS SITE, REQUIRING MANUAL COMPRESSION. A PRODUCT QUALITY OR INSPECTION DEFICIENCY WAS NOT DETECTED DURING THE INVESTIGATION. WHILE A DEFINITIVE CAUSE WAS DETERMINED IN THIS INCIDENT, NO PRODUCT MALFUNCTION, FAILURE OR DETERIORATION OF CHARACTERISTIC OR PERFORMANCE OF THE DEVICE OR INADEQUACY IN THE LABELING AND/OR IFU WAS IDENTIFIED. TO ASSURE THE DEVICE OPERATES ACCORDING SPECIFICATIONS THE FLEX-GUIDE AND TUBESET ASSEMBLIES THEY ARE SUBJECT TO AN INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN EMBOLIZATION OF A CRANIAL FISTULA PROCEDURE THROUGH A 6F SHEATH, ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A STARCLOSE SE DEVICE. REPORTEDLY, AFTER DEPRESSING THE PLUNGER TO DEPLOY THE LOCATOR WINGS, THE THUMB ADVANCER AND CLIP DELIVERY TUBESET COULD NOT BE DISTALLY ADVANCED. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, A DILATOR WAS INSERTED INTO THE ACCESS PORTS UNLOCKING THE THUMB ADVANCER AND CLIP DELIVERY TUBESET ENABLING THEM TO BE RETRACTED PROXIMALLY, AND THE SAFETY RELEASE WAS ACTIVATED THAT RETRACTED THE LOCATOR WINGS AND RELEASED THE DEVICE FROM THE PATIENT ANATOMY. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. IT WAS BELIEVED THAT "POSSIBLE SCAR TISSUE BUT NOT MUCH" AT THE TARGET GROIN FROM A PRIOR ARTERIOTOMY MAY HAVE PLAYED A ROLE IN THE PRODUCT EXPERIENCE. 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 960246H

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention PROCEDURAL SHEATH CORDIS 6F