BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APERTA NSE CORONARY DILATATION CATHETER

    MDR report key: 22049478 · Received May 20, 2025

    Report

    Report Number
    3007835716-2025-00050
    Event Type
    Injury
    Date Received
    May 20, 2025
    Manufacturer
    GOODMAN CO., LTD.
    Product Code
    NWX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED AND THERE WAS NOT ENOUGH INFORMATION AVAILABLE. THEREFORE, IT WAS NOT POSSIBLE TO CONDUCT A DETAILED INVESTIGATION OF THE PRODUCT OR TO CHECK THE MANUFACTURING AND INSPECTION RECORDS. IT IS CONSIDERED THAT THE CONDITION OF THE LESION INFLUENCED THIS INCIDENT, LEADING TO DAMAGE TO THE BLOOD VESSELS WHEN THE PRODUCT WAS EXPANDED, BUT THE DETAILED CAUSE COULD NOT BE IDENTIFIED. THE INSTRUCTIONS FOR USE (IFU) PROVIDE GENERAL INSTRUCTIONS FOR USE, WARNINGS AND PRECAUTIONS RELATED TO THE DEVICE, AND INFORMATION TO MAKE YOU AWARE OF POTENTIAL COMPLICATIONS AND OTHER EVENTS SIMILAR TO THIS EVENT THAT MAY OCCUR. THIS REPORT DOES NOT IMPLY AN ADMISSION BY ANYONE THAT THE PRODUCTS MENTIONED IN THIS REPORT ARE DEFECTIVE.

    Description of Event or Problem · 0

    IT WAS INFORMATION THAT CORONARY ARTERY PERFORATION OCCURRED DURING THE DILATION OF THE PRODUCT IN QUESTION. AFTER DEBULKING WITH A ROTABLATOR, THE DISTAL SIDE WAS DILATED WITH A CUTTING BALLOON CATHETER AND THE PROXIMAL SIDE WITH THIS PRODUCT. THEREAFTER, A STENT WAS IMPLANTED ON THE DISTAL SIDE, AND A CORONARY PERFORATION OCCURRED NEAR THE ENTRANCE OF THE LEFT ANTERIOR DESCENDING BRANCH DURING DILATION OF THE CATHETER BEFORE IMPLANTATION OF A SECOND STENT OF A LARGER SIZE ON THE PROXIMAL SIDE. THEREAFTER, A BALLOON CATHETER WAS USED TO DILATE THE AREA IN FRONT OF THE PERFORATION AND A PERFUSION BALLOON CATHETER WAS USED TO TRY TO STOP THE BLEEDING, BUT THIS FAILED, SO A COVERED STENT WAS PLACED. HOWEVER, THE PATIENT CONTINUED TO BLEED AND COULD NOT BE HEMOSTATICALLY STOPPED WITH AN ADDITIONAL COVERED STENT, SO A SMALL-DIAMETER BALLOON WAS USED FOR POST-DILATION. AT THAT TIME, THE SMALL-DIAMETER BALLOON BECAME DIFFICULT TO REMOVE, RESULTING IN ISCHEMIA OF THE LEFT CIRCUMFLEX ARTERY, AND THE PATIENT WENT INTO SHOCK FROM ST-SEGMENT ELEVATION, SO A BALLOON-PUMPING CATHETER WAS PLACED IN THE AORTA. AFTER BALLOON DILATION, GOOD BLOOD FLOW WAS OBTAINED, ECG CHANGES IMPROVED, AND THE PROCEDURE WAS COMPLETED. THIS INFORMATION IS TAKEN FROM THE LITERATURE. (CORONARY INTERVENTION VOL.21 NO.2 2025).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2050083 APERTA NSE CORONARY DILATATION CATHETER Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring NWX GOODMAN CO., LTD. APN30013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention