BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCUNET EMBOLIC PROTECTION SYSTEM

    MDR report key: 2072146 · Received April 28, 2011

    Report

    Report Number
    2024168-2011-02977
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 29, 2010
    Report Date
    April 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K052166
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. THERE ARE SEVERAL POSSIBLE CAUSES FOR DIFFICULTY ADVANCING THE RECOVERY CATHETER, INCLUDING, BUT NOT LIMITED TO, DAMAGE TO THE RECOVERY CATHETER, CHALLENGING ANATOMICAL CONDITIONS, STENT POST DILATATION STRATEGY, THE NEWLY DEPLOYED STENT NOT BEING FULLY APPOSED TO THE VESSEL WALL, LACK OF GUIDE CATHETER SUPPORT OR INTERACTION BETWEEN ASSOCIATED DEVICES. IN THIS CASE, BASED ON THE REPORTED INFORMATION, IT APPEARS THAT THE DIFFICULTY ADVANCING THE RECOVERY CATHETER MAY BE DUE TO THE TIP BECOMING KINKED OR CRIMPED DUE TO INTERACTION WITH THE SHUTTLE SHEATH. THERE WAS NO DAMAGE NOTED TO THE RECOVERY CATHETER PRIOR TO USE, SUGGESTING THAT THE REPORTED DAMAGE LIKELY OCCURRED DURING THE ATTEMPT TO RETRIEVE THE FILTER. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. ADDITIONALLY, THE LOT RELEASE TESTING RESULTS WERE REVIEWED AND THIS LOT MET ALL RELEASE CRITERIA. THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT COMMON CAROTID ARTERY STENTING PROCEDURE, DURING RECOVERY OF THE RX ACCUNET EMBOLIC PROTECTION DEVICE (EPD), THE TIP OF THE LOW PROFILE FLEXIBLE DESIGN RECOVERY CATHETER (RC) BECAME CRIMPED FROM THE SHUTTLE SHEATH AND WOULD NOT CAPTURE THE EPD. A SHAPEABLE TIP RC WAS USED TO SUCCESSFULLY CAPTURE THE EPD. THERE WAS NO ADVERSE PATIENT SEQUELA AND ONE DAY POST-PROCEDURE, THE PATIENT WAS DISCHARGED TO HOME. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCUNET EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT 8112651

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention RX ACCULINK