BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARSTASIS ACCESS SYSTEM

    MDR report key: 1943592 · Received December 9, 2010

    Report

    Report Number
    3008493244-2010-00011
    Event Type
    Other
    Date Received
    December 9, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 10, 2010
    Manufacturer
    ARSTASIS INC.
    Product Code
    DYB
    PMA / PMN Number
    K102728
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND FAILURE ANALYSIS PERFORMED AND DOCUMENTED. BASED ON THE DESCRIPTION OF EVENT, THE DEVICE WAS MISSING THE DISTAL PORTION OF THE DEVICE SHEATH BELOW THE EXIT PORT. DETACHMENT OF THE SHEATH/FRACTURE OF THE CORE WIRE OCCURRED UPON REMOVAL OF THE DEVICE. THE ANALYSIS FOUND THAT THE SHEATH DETACHED NEAR THE EXIT PORT. INSPECTION OF THE RETURNED DEVICE AND REVIEW OF MANUFACTURING RECORDS COULD NOT IDENTIFY A ROOT CAUSE FOR THE REPORTED EVENT. ONE HYPOTHESIS IS THAT DURING ADVANCEMENT OF THE GUIDEWIRE, THE GUIDEWIRE ROUTED BACK INTO THE EXIT PORT OF THE DEVICE SHEATH THEREBY PLACING STRESS ON THE SHEATH DURING DEVICE REMOVAL AND CAUSING THE SEPARATION OF THE DISTAL PORTION OF THE SHEATH, HOWEVER, THIS IS INCONSISTENT WITH THE DOCTOR'S REPORT OF NO UNUSUAL RESISTANCE ENCOUNTERED. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) HAS BEEN OPENED TO CONTINUE THE INVESTIGATION INTO THIS EVENT.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS PERFORMING A DIAGNOSTIC PROCEDURE ON AN AVERAGE SIZED PT. THE GROIN AREA WAS UNREMARKABLE IN THAT THE PHYSICIAN DID NOT NOTE ANY UNUSUAL RESISTANCE TO INSERTION, NO UNUSUAL ANATOMY OR SCARRING. UPON REMOVAL OF THE DEVICE THE PHYSICIAN NOTED THAT THE DISTAL 3CMS OF THE SHEATH WAS MISSING. HE WENT IN CONTRALATERALLY AND USED A SNARE TO PULL OUT THE SEPARATED PIECE. THE PROCEDURE COMPLETED SUCCESSFULLY AND THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARSTASIS ACCESS SYSTEM INTRODUCER CATHETER DYB ARSTASIS INC. 1I16416

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention