BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TYSHAK II VALVULOPLASTY CATHETER

    MDR report key: 8090911 · Received November 20, 2018

    Report

    Report Number
    1318694-2018-00015
    Event Type
    Injury
    Date Received
    November 20, 2018
    Date of Event
    October 30, 2018
    Report Date
    November 20, 2018
    Manufacturer
    NUMED, INC.
    Product Code
    LIT
    UDI-DI
    04046964339417
    PMA / PMN Number
    K003052
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CATHETER WAS NOT RETURNED SO ANALYSIS OF THE COMPLAINT CATHETER WAS NOT POSSIBLE. A REVIEW OF THE DHR WAS PERFORMED AND NO ISSUES WERE FOUND. NUMED RECEIVED THIS REPORT FROM THE RECEIPT OF A MEDWATCH FORM FILLED OUT BY THE USER FACILITY THAT WAS MAILED TO NUMED. IN THE REPORT THE USER FACILITY STATES THAT THEY ARE NOT SENDING THE REPORT TO THE FDA. THE USER FACILITY STATED THAT THEY WERE USING THIS DEVICE FOR "VALULOPLASTY" WITH A PREVIOUSLY PLACED EDWARDS SAPIEN VALVE. THE SAPIEN VALVE IS AN AORTIC/MITRAL VALVE REPLACEMENT, WHICH MAKES THIS AN OFF-LABEL USE OF THE TYSHAK II CATHETER. THE TYSHAK II CATHETER IS ONLY APPROVED FOR VALVULOPLASTY OF THE PULMONARY VALVE. IT WAS ALSO DETERMINED THAT THE USER FACILITY DID NOT USE AN INFLATION DEVICE WITH PRESSURE GAUGE TO MONITOR THE INFLATION PRESSURE. THE REPORT STATES THAT THE BALLOON BURST AT MAXIMUM INFLATION; HOWEVER, WITHOUT THE GAUGE, THEY WOULD NOT BE ABLE TO TELL THE PRESSURE THAT THEY TOOK THE BALLOON TO BEFORE IT BURST. THE IFU STATES TO USE AN INFLATION DEVICE WITH PRESSURE GAUGE TO MONITOR PRESSURE. ANY PRESSURES THAT EXCEED THE LABELED RBP COULD RESULTS IN A BALLOON BURST. THE MEDWATCH REPORT ALSO STATES THAT RESISTANCE WAS FELT DURING THE REMOVAL OF THE BURST BALLOON. THERE IS A PRECAUTION IN THE INSTRUCTIONS FOR USE THAT STATES THAT WHEN RESISTANCE IS FELT UPON REMOVAL, THE BALLOON, GUIDEWIRE AND SHEATH SHOULD BE REMOVED TOGETHER AS A UNIT, PARTICULARLY IF BALLOON RUPTURE OR LEAKAGE IS KNOWN OR SUSPECTED. A COMPARATIVE CATHETER WAS PULLED AND TESTED FOR RATED BURST PRESSURE. THE COMPARATIVE CATHETER IS THE SAME EXACT CATHETER CATALOG NUMBER, BUT A DIFFERENT LOT NUMBER. THE BALLOON WAS IMMERSED IN A BODY TEMPERATURE WATER BATH AND INFLATED UNTIL IT FAILED. THE LABELED RBP FOR THIS DEVICE IS 2.0 ATM. THE COMPARATIVE CATHETER DID NOT BURST UNTIL 3.5 ATM, WHICH IS WELL ABOVE THE LABELED RBP.

    Description of Event or Problem · 1

    DESCRIPTION TAKEN DIRECTLY FROM A MEDWATCH REPORT RECEIVED DIRECTLY FROM THE USER FACILITY: WITH THE USE OF FLUOROSCOPIC AND VASCULAR ULTRASOUND GUIDANCE, THE RIGHT COMMON FEMORAL ARTERY WAS ACCESSED. ANGIOGRAPHY REVEALED GOOD CATHETER POSITIONING WITH A MICROPUNCTURE KIT AND A SINGLE PERCLOSE PROGLIDE DEVICE WAS PLACED AND THEN A 9 FRENCH SHEATH WITHOUT DIFFICULTY. HEPARIN WAS THEN ADMINISTERED AT FULL DOSAGE. DUE TO THE RIGHT FEMORAL ARTERY SHEATH, A PIGTAIL CATHETER WAS ADVANCED TO THE LEVEL OF THE EDWARDS SAPIEN VALVE AND THE VALVE WAS CROSSED WITHOUT DIFFICULTY. THROUGH THE PIGTAIL CATHETER, A SAFARI EXTRA SMALL WIRE WAS PLACED IN THE LV APEX AND THE PIGTAIL CATHETER WAS SUBSEQUENTLY REMOVED. OVER THIS WIRE, A TYSHAK 23 MM BALLOON WAS PASSED AND ACROSS THE NATIVE VALVE WITHOUT DIFFICULTY. RAPID VENTRICULAR PACING WAS PERFORMED WITH THE ASSISTANCE OF A PACEMAKER REP WITH A MAXIMUM RATE OF 170 WITH GOOD DROP IN SYSTOLIC PRESSURE AND VERY LOW PULSE PRESSURE. THE BALLOON IS FULLY INFLATED AND AT MAXIMUM INFLATION, THE BALLOON DID RUPTURE. THE BALLOON CATHETER WAS WITHDRAWN TO THE LEVEL OF THE SHEATH MAKING SURE THAT THE BALLOON MARKER ARE IN PLACE. THERE WAS SOME RESISTANCE TO REMOVING THE BALLOON CATHETER THROUGH THE SHEATH AND WHEN THE BALLOON CATHETER EXITS, THE SHEATH IS CLEAR THAT THERE IS AN APPARENT LARGE PORTION OF THE RUPTURED BALLOON MISSING FROM THE CATHETER. THE RADIOPAQUE PORTION OF THE BALLOON REMAINS WITHIN THE FEMORAL ARTERY SHEATH AND MARKERS ARE REMOVED IN TOTAL UNDER FLUOROSCOPIC GUIDANCE. THE SAFARI WIRE IS CUT SHORT AND A NEW 9 FRENCH SHEATH WAS INTRODUCED WITHOUT DIFFICULTY. SUBTRACTION ANGIOGRAPHY OF THE AORTIC ARCH, DESCENDING THORACIC AND ABDOMINAL AORTA AND ILIAC SYSTEM DID NOT REVEAL ANY APPARENT FILLING DEFECTS. THERE IS SOMEWHAT REDUCED FLOW AROUND THE 9 FRENCH SHEATH, BUT THIS IS INSERTED IN AN AREA OF KNOWN VASCULAR DISEASE AND DOES NOT APPEAR DIFFERENT THAN THAT PRIOR TO SHEATH PLACEMENT. SURGEONS DID NOT FEEL THAT THEY HAD ANYTHING FURTHER TO OFFER PERCUTANEOUSLY. PATIENT MONITORED CLOSELY. THE NEXT DAY PATIENT DEVELOPED RIGHT LOWER EXTREMITY ISCHEMIA REQUIRING EMERGENT FEMORAL ENDARTERECTOMY. ON (B)(6) 2018 A LIMITED RIGHT LOWER EXTREMITY ARTERIAL DUPLEX WAS PERFORMED. WAVEFORMS AND VELOCITIES SUGGEST HEMODYNAMICALLY SIGNIFICANT STENOSIS PROXIMAL TO THE VISUALIZED ARTERIES OF THE RIGHT LOWER EXTREMITIES. "PATEINT" WAS THEN TAKEN TO SURGERY FOR AN EMERGENT RIGHT FEMORAL ENDARTERECTOMY WITH FOREIGN BODY RETRIEVAL OF BALLOON FRAGMENT WITH XENOSURE PATCH. BLOOD FLOW WAS RESTORED TO THE PATIENTS LOWER EXTREMITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932585 TYSHAK II VALVULOPLASTY CATHETER PERCUTANEOUS TRAMSLUMINAL VALVULOPLASTY CATHETER LIT NUMED, INC. 105 TT-11790 04046964339417

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention