BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYSHAK II

    MDR report key: 4999724 · Received August 6, 2015

    Report

    Report Number
    1318694-2015-00005
    Event Type
    Malfunction
    Date Received
    August 6, 2015
    Date of Event
    July 7, 2015
    Report Date
    August 6, 2015
    Manufacturer
    NUMED, INC.
    Product Code
    DQY
    PMA / PMN Number
    K003052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE RETURNED BUT AN EVAL COULD NOT BE PERFORMED ON IT DUE TO THE CONDITION OF THE DEVICE UPON RETURN. THE BALLOON BURST WAS VISUALLY CONFIRMED. A SAMPLE WAS PULLED FROM INVENTORY AND TESTED FOR RBP SPECS. THIS CATHETER HAS A NOMINAL PRESSURE OF 1.5 ATM AND A RBP OF 2 ATM. THE SAMPLE CATHETER DID NOT BURST UNTIL 3.0 ATM. THIS CATHETER WAS BEING USED IN A BIOPROSTHETIC VALVE WITH CALCIFIED LEAFLETS. THE PATIENTS CONDITION AND THE BIOPROSTHETIC VALVE CONTRIBUTED TO THE BALLOON BURST. THE PHYSICIAN ALSO STATED THAT THE DEVICE BURST AT A LOW ATM, HOWEVER, THIS CATHETER IS A LOW ATM CATHETER. FURTHER CLARIFICATION FROM THE FACILITY CONFIRMED THAT THE BALLOON BURST BETWEEN 1 AND 2 ATM. THE NOMINAL PRESSURE FOR THIS BALLOON IS 1.5 ATM AND THE RBP IS 2 ATM. A HIGHER ATM CATHETER SHOULD HAVE BEEN USED FOR THIS PROCEDURE.

    Description of Event or Problem · 1

    PER THE COMPLAINT REC'D: "BALLOON BURST AND UPON RETRIEVAL, WRAPPED AROUND THE WIRE. BALLOON AND INTRODUCER SHEATH HAD TO BE REMOVED AS ONE. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. THE BALLOON RUPTURED CIRCUMFERENTIALLY. THE PHYSICIAN WAS USING THE BALLOON FOR PULMONARY VALVULOPLASTY. AN INFLATION DEVICE WITH PRESSURE GAUGE WAS USED. THE SHAFT WAS NOT KINKED. THERE WAS NOTHING UNUSUAL WITH THE PATIENT ANATOMY, HOWEVER, THE PATIENT HAS A PROSTHETIC VALVE IN A HOMOGRAFT CONDUIT IJ APPROACH. THE BALLOON RUPTURED AT LOW ATM. THE PATIENT'S CONDITION POST PROCEDURE WAS GOOD." FURTHER CLARIFICATION WAS PROVIDED AT A LATER DATE: "THE PHYSICIAN WAS USING THE BALLOON FOR ANGIOPLASTY OF BIOPROSTHETIC PULMONARY VALVE. THE PATIENT HAS CALCIFIED LEAFLETS AND A PROSTHETIC VALVE IN A HOMOGRAFT CONDUIT. BALLOON WAS INSERTED THROUGH 9FR SHEATH IN THE RIGHT IJ VEIN OVER A 0.035 AMPLATZ SUPERSTIFF WIRE POSITIONED IN THE RPA. THE BALLOON RUPTURED AT: 1-2 ATM (DURING INFLATION, NOT COMPLETELY INFLATED). PART OF THE BALLOON SHAFT SEEMED TO BE ATTACHED TO THE WIRE. THE WIRE WOULD NOT COME BACK FARTHER TO GET THE REST OF THE BALLOON OUT OF THE BODY. ACCOUNT PLACED PURESTRING SUTURE AROUND THE IJ TO PREVENT BLEEDING AND FORCEFULLY PULLING THE WIRE OUT. THIS REMOVED THE REST OF THE BALLOON FROM THE BODY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520490 TYSHAK II PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER DQY NUMED, INC. 105 TT-7421

    Patients

    Seq Age Sex Outcome Treatment
    1