BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Z-MED II CATHETER

    MDR report key: 8056246 · Received November 9, 2018

    Report

    Report Number
    1318694-2018-00014
    Event Type
    Injury
    Date Received
    November 9, 2018
    Date of Event
    October 18, 2018
    Report Date
    November 9, 2018
    Manufacturer
    NUMED, INC.
    Product Code
    LIT
    UDI-DI
    04046964337734
    PMA / PMN Number
    K003052
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RETURNED IN A PLASTIC BAG. THE BALLOON HAS A LATERAL TEAR AND ALSO A CIRCUMFERENTIAL TEAR. THE DISTAL END OF THE BALLOON , ALONG WITH THE ENTIRE LENGTH OF THE GUIDEWIRE TUBING IS DETACHED. THE GUIDEWIRE IS STILL IN THE GUIDEWIRE TUBING. THE GUIDEWIRE TUBING HAS BEEN STRETCHED OVER THE WIRE. THE DETACHED PORTION OF THE BALLOON HAS BEEN PARTIALLY FOLDED UNDER ITSELF. THIS APPEARS TO HAVE BENN CAUSED BY THE INTRODUCER. A COMPARATIVE CATHETER OF THE SAME CATALOG NUMBER WAS TESTED FOR RATED BURST PRESSURE. THE BALLOON WAS IMMERSED IN A BODY TEMPERATURE WATER BATH AND INFLATED UNTIL IT FAILED. THERE WAS A LONGITUDINAL TEAR AT 8 ATM, WHICH IS DOUBLE THE LABELED RATED BURST PRESSURE OF 4 ATM. IT IS LIKELY THAT THE CALCIUM SPICULE CAUSED THE BALLOON BURST AND THEN THE DETACHMENT OCCURRED WHEN THE PHYSICIAN ATTEMPTED TO PULL THE BALLOON BACK THROUGH THE INTRODUCER SHEATH. THE INSTRUCTIONS FOR USE HAS THE FOLLOWING PRECAUTION REGARDING THIS ISSUE: "IF RESISTANCE IS FELT UPON REMOVAL, THEN THE BALLOON AND THE SHEATH SHOULD BE REMOVED TOGETHER AS A UNIT, PARTICULARLY IF BALLOON RUPTURE OR LEAKAGE IS KNOWN OR SUSPECTED. THIS MAY BE ACCOMPLISHED BY FIRMLY GRASPING THE BALLOON CATHETER AND SHEATH AS A UNIT AND WITHDRAWING BOTH TOGETHER, USING A GENTLE TWISTING MOTION COMBINED WITH TRACTION."

    Description of Event or Problem · 1

    AS REPORTED TO NUMED BY THE USER FACILITY AND THE DISTRIBUTOR (B)(4) - "BALLOON RUPTURED CIRCUMFERENTIALLY AT 4 ATM ON A CALCIUM SPICULE IN THE PULMONIC ANNULUS. UPON BALLOON RUPTURE, PHYSICIAN WITHDREW PROXIMAL PORTION OF BALLOON TOWARDS INTRODUCER SHEATH AND NOTED THAT THE DISTAL PORTION OF BALLOON CATHETER SHAFT AND BALLOON REMNANTS WERE NOT TRACKING PROPERLY OVER THE WIRE AND COULD NOT BE WITHDRAWN THOUGH THE 12F COOK SHEATH. PHYSICIAN NOTED THAT THE DISTAL REMNANTS HAD SEPARATED FROM THE PROXIMAL PORTION OF THE BALLOON CATHETER AND HAD TO BE SNARED VIA AN 18F SHEATH (ACCESS POINT LEFT FEMORAL). ALL COMPONENTS OF BALLOON ALONG WITH THE GUIDEWIRE WILL BE RETURNED FOR EVALUATION/ANALYSIS. THE INDICATION THE PHYSICIAN WAS USING THE BALLOON FOR: PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY (PTV). AN INFLATION DEVICE WITH PRESSURE GAUGE WAS USED. THE SIZE AND TYPE OF INTRODUCER SHEATH USED: 12F X 13CM COOK CHECK-FLO INTRODUCER SET. THE CATHETER SHAFT WAS NOT KINKED. AN ATLAS GOLD 22X4X120 WAS USED TO COMPLETE THE PROCEDURE. BALLOON RUPTURED CIRCUMFERENTIALLY AT 4 ATM. BALLOON DISTAL REMNANTS SEPARATED FROM THE PROXIMAL PORTION OF THE BALLOON CATHETER AND HAD TO BE SNARED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893874 Z-MED II CATHETER PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER LIT NUMED, INC. 305 ZZ-9241 04046964337734

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention