BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX ACCUNET EMBOLIC PROTECTION SYSTEM

    MDR report key: 1315985 · Received December 2, 2008

    Report

    Report Number
    3004742046-2008-00293
    Event Type
    Malfunction
    Date Received
    December 2, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 6, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NFA
    PMA / PMN Number
    K052166
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY EVENT. THE RX ACCUNET PART # 1011649-55 LOT# 8051251, WAS FILED UNDER MANUFACTURER REPORT NUMBER 3004742046-2008-00261. EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE ACCUNET WAS RETURNED WITH BLOOD VISIBLE IN THE BASKET AND IN THE PEEL AWAY SHEATH. THERE WAS NO CONTRAST VISIBLE. THE PEEL AWAY WAS PEELED APART FOR A LENGTH OF 32.5 CM DISTAL TO THE PROXIMAL END. THE TORQUE DEVICE WAS LOOSELY ATTACHED TO THE GUIDE WIRE. THE COIL DISPENSER WAS RETURNED WITH THE FLUSHING TOOL ATTACHED, BUT THE DEVICE WAS NOT IN THE COIL DISPENSER. THERE WERE TWO KINKS IN THE PROXIMAL END OF THE GUIDE WIRE. THERE WAS A BROKEN BASKET STRUT. THERE WAS NO DAMAGE NOTED TO THE BASKET OR THE REST OF THE ACCUNET. DURING FUNCTIONAL ANALYSIS, AN ATTEMPT WAS MADE TO RETRACT THE FILTER BASKET, BUT DUE TO THE BROKEN BASKET STRUT, THE BASKET COULD NOT COMPLETELY COLLAPSE INTO THE SHEATH. AFTER ALIGNMENT OF THE BROKEN BASKET STRUT WITH THE DISTAL END OF THE PEEL AWAY SHEATH, IT WAS POSSIBLE TO SLIGHTLY PULL THE GUIDE WIRE AND RETRACT THE BASKET BACK IN TO THE SHEATH SUCCESSFULLY. THE TORQUE DEVICE WAS ATTACHED TO THE PROXIMAL END OF THE UNPEELED SECTION OF THE SHEATH AND WAS TIGHTENED. THE PEEL AWAY SHEATH WAS UNPEELED AND FUNCTIONED NORMALLY AND THE FILTER BASKET WAS THEN DEPLOYED WITHOUT ANY RESISTANCE. ENGINEERING WAS UNABLE TO CONCLUSIVELY CONFIRM THE REPORTED DEVICE DISCREPANCY. THE RX ACCUNET INSTRUCTIONS FOR USE (IFU) NOTES ON TECHNIQUES THAT CAN BE USED FOR FILTER BASKET POSITIONING AND EXPANSION. "CAUTION: ENSURE THAT THE TORQUE DEVICE IS SECURED TIGHTLY TO THE GUIDE WIRE TO AVOID DIFFICULTIES WITH DEPLOYMENT. IF THE TORQUE DEVICE IS NOT TIGHTENED SECURELY ON THE GUIDE WIRE, PROPER DEPLOYMENT MAY NOT OCCUR". "NOTE: AVOID EXCESSIVE MOVEMENT OF THE FILTER BASKET DURING UNSHEATHING BY REMOVING ALL SLACK BETWEEN THE PATIENT, GUIDING CATHETER OR SHEATH AND DELIVERY SYSTEM." THE CAUSE OF THE KINKS IS UNDETERMINED; HOWEVER, THEY MAY HAVE OCCURRED DURING SHIPPING. IN ADDITION, DURING FILTER BASKET EXAMINATION, A BROKEN BASKET STRUT WAS IDENTIFIED AND IT IS UNCLEAR AS TO HOW THIS DAMAGE OCCURRED. IT IS POSSIBLE THAT THE STRUT ALSO GOT DAMAGED DURING SHIPPING. THE CONCLUSIVE ROOT CAUSE FOR THE INABILITY TO DEPLOY THE FILTER BASKET DUE TO PEEL AWAY ISSUES COULD NOT BE DETERMINED; HOWEVER, IT DOES NOT APPEAR TO BE RELATED TO DEVICE QUALITY ISSUE. ALL RX ACCUNET DEVICES UNDERGO 100% VISUAL INSPECTION IN THE MANUFACTURING PROCESS AT ABBOTT VASCULAR. THE DEVICE ON-LINE RELIABILITY ENGINEERING SAMPLE TESTING FOR THIS LOT MET SPECIFICATIONS AND THE INSPECTION DATA SHOWED THAT THE FILTER BASKET/GUIDE WIRE (I.E. DISTAL TIP COIL OR BASKET/FILTER ASSEMBLY) AND PEEL AWAY FUNCTION PASSED THE VISUAL AND DIMENSIONAL INSPECTIONS AND FUNCTIONAL TESTS. NO INCIDENT SIMILARITY WAS ESTABLISHED WITH THIS PART AND LOT NUMBER COMBINATION. PRODUCT PERFORMANCE ENGINEERING WILL CONTINUE TO MONITOR THIS TYPE OF COMPLAINT. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES, WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: BROKEN BASKET STRUT. TIME OF MALFUNCTION: UNKNOWN. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING A RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE, THE FILTER BASKET MET RESISTANCE DEPLOYMENT AND THE PEELAWAY SHEATH COULD NOT BE REMOVED. THE ACCUNET WAS REMOVED WITHIN THE SHEATH WITHOUT INCIDENT. SUBSEQUENT TO RECEIVING THIS INFORMATION, AFTER THE DEVICE WAS EVALUATED, THE DEVICE WAS FOUND TO HAVE A BROKEN BASKET STRUT. THE REPORT SOURCE WAS CONTACTED, BUT WAS UNABLE TO REMEMBER DETAILED INFORMATION ABOUT THE CONDITION OF THE BASKET STRUT, THEREFORE, IT IS UNKNOWN IF THE BREAKAGE OCCURED DURING THE PROCEDURE, DURING PACKAGING OR DURING SHIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCUNET EMBOLIC PROTECTION SYSTEM NFA ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 8032151

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR RX ACCULINK| RX ACCUNET PART # 1011649-55| HEPARIN