BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMER MULLINS GUIDING SHEATH

    MDR report key: 2021932 · Received March 11, 2011

    Report

    Report Number
    1820334-2011-00129
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    January 19, 2011
    Report Date
    February 17, 2011
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT HAS NOT BEEN RETURNED TO ASSIST IN THIS INVESTIGATION. PRODUCT QUALITY CONTROL SPECIFICATION, IT REQUIRES 100% VISUAL INSPECTION OF TIP/TUBING BOND FOR OUTSIDE AND INSIDE DIAMETER. IN ADDITION, TENSILE STRENGTH OF THE TIP TO SHAFT BOND IS EVALUATED ON TWO SAMPLES FROM EACH LOT. THE PROCESS OF BONDING THIS TIP TO THIS SHAFT HAS BEEN VALIDATED. THIS DEVICE IS SUPPLIED WITH AN IFU, WHICH UNDER "PRECAUTIONS" STATES: "THE MAXIMUM DIAMETER OF THE INSTRUMENT OR CATHETER TO BE INTRODUCED SHOULD BE DETERMINED TO ENSURE ITS PASSAGE THROUGH THE INTRODUCER. ALL INSTRUMENTS OR CATHETERS USED WITH THIS PRODUCT SHOULD MOVE FREELY THROUGH THE VALVE AND SHEATH. DAMAGE TO THE VALVE/INTRODUCER MAY RESULT WHEN FIT IS TIGHT." WHILE NO PRODUCT WAS RETURNED TO ASSIST IN THIS INVESTIGATION, THE TENSILE STRENGTH OF THE BONDED SHAFT USED TO BUILD THIS DEVICE FROM THIS LOT NUMBER WAS RECORDED ON THE WORK ORDER AS 14.45 AND 14.71 LBS EXCEEDING THE (B)(4) REQUIRED BY QUALITY CONTROL SPECIFICATION. WITHOUT BENEFIT OF EXAMINING THE COMPLAINT DEVICE, IT REMAINS UNK AS TO WHICH PART OF THE SHEATH SEPARATED; HOWEVER, BASED ON COMPLAINT HISTORY, THE MOST LIKELY FAILURE MODE IS TIP SEPARATION. UNFORTUNATELY, IT IS DIFFICULT TO DETERMINE WITH CERTAINTY WHY THE CUSTOMER EXPERIENCED THIS FAILURE MODE FOR THIS PRODUCT. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED OF THIS EVENT AND WE ARE CONTINUING TO MONITOR COMPLAINTS FROM THE SAME FAILURE MODE IN THIS PRODUCT FAMILY. RISK ANALYSIS WAS PERFORMED BY QUALITY ENGINEERING FOR THIS FAILURE MODE AND PRODUCT FAMILY. WITH THE ADDITION OF THIS COMPLAINT, THE RISK REMAINS ACCEPTABLE AND NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    INFO PROVIDED FROM A USER FACILITY MEDWATCH REPORT: THE PT HAS HISTORY OF TETRALOGY OF FALLOT, PULMONARY ATRESIA AND MAPCAS AS DIGEORGE SYNDROME. THE PT DEVELOPED RVOT OBSTRUCTION WITH A GRADIENT OF 45-50 MMHG AND WAS THEREFORE REFERRED FOR CARDIAC CATHETERIZATION WITH MELODY VALVE INSERTION THROUGH THE CONDUIT. CHILD HAD CONDUIT PRE-DILATED WITH A 16 MM ATLAS BALLOON, 12-FR SHEATH THROUGH A 16-FR SHORT SHEATH, AND THEN STENTED WITH TWO STENTS. NO GRADIENT WAS NOTED AFTER THE STENTING. AFTER THE FIRST STENT PLACEMENT WITH REMOVAL OF THE BALLOON, PART OF THE 12-FR LONG SHEATH FRACTURED AND MIGRATED TO THE DISTAL RIGHT PULMONARY ARTERY (RPA) BRANCH. A TRANSCATHETER PULMONARY VALVE ON AN 18 MM ENSEMBLE DELIVERY SYSTEM WAS DELIVERED. INFO REGARDING OUTCOME/CONDITION OF THE PT WAS NOT PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFORMER MULLINS GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK, INC. NA 2589657

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR