BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGUARD RX

    MDR report key: 1820512 · Received August 30, 2010

    Report

    Report Number
    1016427-2010-00096
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 15, 2010
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FILTER BASKET OF ANGIOGUARD RX WAS PROPERLY DOCKED IN THE DEPLOYMENT SHEATH TIP AND WHEN THE DEVICE WAS REMOVED THE COIL DISPENSER THE FILTER GUIDEWIRE PREMATURELY CAME OUT FROM THE MIDDLE OF THE PEEL AWAY SLIT OF THE INTRODUCER. MANUAL RE-INSERTION OF THE GUIDEWIRE INTO THE SHEATH WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEW PRODUCT. ANALYSIS OF THE RETURNED PRODUCT FOUND THAT THE FILTER BASKET WAS DEPLOYED WITH MEMBRANE DAMAGE. WITH FOLLOW-UP INVESTIGATION, IT WAS REPORTED THAT IT IS UNKNOWN WHEN THIS DAMAGE OCCURRED, BUT POSSIBLE DURING THE PREPARATION. THE DEVICE WAS PREPPED AS PER THE IFU. IT IS UNKNOWN IF THE DEPLOYMENT SHEATH TIP WAS STILL FULLY SEATED IN THE FILTER BASKET INTRODUCER. NO EXCESSIVE FORCE WAS USED TO DOCK THE FILTER BASKET. THERE WAS NO DIFFICULTY FLUSHING THE FILTER INTRODUCER AND DEPLOYMENT SHEATH AND SALINE WAS NOTED WITHIN THE COIL DISPENSER AT THE GREEN DEPLOYMENT SHEATH HUB. THE TORQUE DEVICE WAS LOCKED ONTO THE GUIDEWIRE. THE ANTI-MIGRATION CLIP LOCATED CLOSEST TO THE FILTER INTRODUCER WAS LEFT IN PLACE UNTIL AFTER THE FILTER BASKET WAS DOCKED INTO THE DEPLOYMENT SHEATH. WHEN DOCKING THE FILTER BASKET INTO THE DEPLOYMENT SHEATH, NO DIFFICULTY WAS ENCOUNTERED AND APPROXIMATELY HALF OF THE FILTER BASKET WAS STILL BE VISIBLE OUT OF THE END OF THE DEPLOYMENT SHEATH. THE PROXIMAL END OF THE DEPLOYMENT SHEATH WAS IN CONTACT WITH THE TORQUE NUT PRIOR TO REMOVING THE DEVICE FROM THE COIL DISPENSER. ONE NON STERILE ANGIOGUARD RX WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE TORQUE DEVICE WAS RECEIVED ATTACHED ON THE PROXIMAL SECTION OF THE CORE WIRE. THE DEPLOYMENT SHEATH WAS FOUND UNZIPPED FROM 30.2CM TO 34.5CM FROM THE DISTAL END. THE FILTER BASKET WAS RECEIVED DEPLOYED AND WITH MEMBRANE DAMAGED. THE COIL TIP PRESENTED A KINK CONDITION AT 1.2CM FROM DISTAL END. THE PEEL AWAY WAS RECEIVED DETACHED FROM THE DEVICE WITHOUT ANY VISUAL DAMAGE. NO OTHER ANOMALIES WERE OBSERVED IN THE UNIT RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. THE REPORTED PREMATURE PEELING OF THE INTRODUCER WAS CONFIRMED WITH ANALYSIS OF THE RETURNED DEVICE. THE DAMAGES FOUND ON THE COIL TIP AND FILTER BASKET MEMBRANE MAY HAVE BEEN CAUSED DURING PREP AND ATTEMPT TO RECAPTURE THE GUIDEWIRE IN THE INTRODUCER. ALTHOUGH NO DEFINITIVE CONCLUSION REGARDING THE ROOT CAUSE CAN BE DETERMINED, IT IS POSSIBLE THAT PROCEDURAL FACTORS/HANDLING DURING PREP MAY HAVE CONTRIBUTED TO THE DAMAGES FOUND ON THE DEVICE. THE DEVICE DID NOT PRESENT WITH ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY CONTRIBUTING TO THE REPORTED EVENT. THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED BY THE AFFILIATE, WHEN THE DEVICE WAS REMOVED FROM A COIL DISPENSER, THE FILTER GUIDEWIRE PREMATURELY CAME OUT FROM THE DEPLOYMENT SHEATH. ALTHOUGH RE-INSERTION OF THE GUIDEWIRE WAS ATTEMPTED MANUALLY, IT DID NOT SUCCEED. THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING AND ANALYSIS SHOWED THAT THE FILTER BASKET WAS RECEIVED DEPLOYED AND WITH MEMBRANE DAMAGED. THE PATIENT WAS A MALE (AGE UNKNOWN). THE TARGET LESION WAS THE INTERNAL CAROTID ARTERY. THE TARGET LESION WAS 95% STENOSED. THE DEVICE WAS PREPPED AS PER THE IFU. IT IS UNKNOWN IF THE DEPLOYMENT SHEATH TIP STILL FULLY SEATED IN THE FILTER BASKET INTRODUCER. NO EXCESSIVE FORCE WAS USED TO DOCK THE FILTER BASKET. THERE WAS NO DIFFICULTY FLUSHING THE FILTER INTRODUCER AND DEPLOYMENT SHEATH AND SALINE WAS NOTED WITHIN THE COIL DISPENSER AT THE GREEN DEPLOYMENT SHEATH HUB. THE TORQUE DEVICE WAS LOCKED ONTO THE GUIDEWIRE. THE ANTI-MIGRATION CLIP LOCATED CLOSEST TO THE FILTER INTRODUCER WAS LEFT IN PLACE UNTIL AFTER THE FILTER BASKET WAS DOCKED INTO THE DEPLOYMENT SHEATH. WHEN DOCKING THE FILTER BASKET INTO THE DEPLOYMENT SHEATH NO DIFFICULTY WAS ENCOUNTERED AND APPROXIMATELY HALF OF THE FILTER BASKET WILL STILL BE VISIBLE OUT OF THE END OF THE DEPLOYMENT SHEATH. THE PROXIMAL END OF THE DEPLOYMENT SHEATH WAS IN CONTACT WITH THE TORQUE NUT PRIOR TO REMOVING THE DEVICE FROM THE COIL DISPENSER. AS PER THE AFFILIATE, IT IS UNKNOWN WHEN THE DAMAGE OCCURRED, BUT POSSIBLY DURING THE PREPARATION. ANOTHER NEW PRODUCT (DETAILS UNK) WAS OPENED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGUARD RX EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION NA 70510506

    Patients

    Seq Age Sex Outcome Treatment
    1