BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOUE BALLOON CATHETER

    MDR report key: 15280155 · Received August 23, 2022

    Report

    Report Number
    9612812-2022-00001
    Event Type
    Injury
    Date Received
    August 23, 2022
    Date of Event
    October 20, 2021
    Report Date
    August 23, 2022
    Manufacturer
    TORAY INDUSTRIES, INC.
    Product Code
    MAD
    PMA / PMN Number
    P910054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    "PERCUTANEOUS CLOSURE OF AN IATROGENIC ATRIAL SEPTAL DEFECT WITH BIDIRECTIONAL SHUNT FOR HEMODYNAMIC COLLAPSE FOLLOWING PERCUTANEOUS TRANSVENOUS MITRAL COMMISSUROTOMY" KAZUNORI SUGIMURA, ET AL., CARDIOVASCULAR INTERVENTION AND THERAPEUTICS, 37(3), P.593-594, 2022. IT IS IMPOSSIBLE TO INVESTIGATE THE DEVICE USED IN THIS PATIENT. WE INVESTIGATED THE MANUFACTURING RECORD AND WE HAVE CONFIRMED THAT THERE WAS NO PROBLEMS OBSERVED WITH THE MANUFACTURING RECORD OR AT THE TIME OF SHIPMENT. WE JUDGED THAT THIS EVENT WAS NOT CAUSED BY MANUFACTURING PROCESS BASED ON THE INVESTIGATION.

    Description of Event or Problem · 0

    THE IATROGENIC ATRIAL SEPTAL DEFECT (IASD) OCCURRED IN THE PATIENT WHO RECEIVED THE PERCUTANEOUS TRANSVENOUS MITRAL COMMISSUROTOMY (PTMC) BY INOUE BALLOON CATHETER. 75-YEAR-OLD WOMAN WITH SEVERE, SYMPTOMATIC MITRAL STENOSIS UNDERWENT PERCUTANEOUS TRANSVENOUS MITRAL COMMISSUROTOMY (PTMC) USING A 24-MM INOUE-BALLOON VIA THE RIGHT COMMON FEMORAL VEIN. HER MITRAL VALVE AREA (MVA) AND MEAN PRESSURE GRADIENT (MPG) MEASURED BY TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) IMPROVED MVA FROM 0.87 TO 1.51 CM2 AND MPG FROM 16 TO 5 MMHG, RESPECTIVELY. HER PULMONARY WEDGE PRESSURE DECREASED FROM 15 TO 13 MMHG, WHEREAS THE RIGHT ATRIAL PRESSURE INCREASED FROM 10 TO 15 MMHG OWING TO LEFT-TO-RIGHT SHUNT THROUGH IATROGENIC ATRIAL SEPTAL DEFECT (IASD). HER CLINICAL COURSE WAS GOOD FOLLOWING THE PROCEDURE. HOWEVER, ON POSTOPERATIVE DAY 5, SHE COMPLAINED OF SEVERE WEAKNESS AND MILD CONFUSION. SHE SUDDENLY EXPERIENCED HEMODYNAMIC COLLAPSE WITH A BLOOD PRESSURE OF 72/42 MMHG, A HEART RATE OF 60 BEATS/MIN, A PERCUTANEOUS OXYGEN SATURATION (SP02) OF 90% ON ROOM AIR, AND METABOLIC ACIDOSIS. A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) SHOWED THAT THE IASD LACERATION WAS 9 MM IN LENGTH AND 3 MM WIDE. THE IASD WAS CLOSED PERCUTANEOUSLY WITH AN 11-MM AMPLATZER SEPTAL OCCLUDER (B)(6). PHYSICIAN'S OPINION REGARDING THIS ADVERSE EVENT: THIS ADVERSE EVENT IS SERIOUS. THE CAUSAL RELATIONSHIP WITH INOUE-BALLOON CANNOT BE RULED OUT. CAUSE OF THE EVENT: ALTHOUGH THE BALLOON WAS SMOOTHLY INSERTED, TAKING IT IN AND OUT SEVERAL TIMES COULD HAVE CAUSED THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2235769 INOUE BALLOON CATHETER CATHETER, PERCUTANEOUS (VALVULOPLASTY) MAD TORAY INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention