BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APERTA NSE CORONARY DILATATION CATHETER

    MDR report key: 21281025 · Received January 31, 2025

    Report

    Report Number
    3007835716-2025-00010
    Event Type
    Injury
    Date Received
    January 31, 2025
    Date of Event
    December 25, 2024
    Manufacturer
    GOODMAN CO., LTD.
    Product Code
    NWX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE PROXIMAL SHAFT WAS SEPARATED AT 820MM FROM THE HUB PART. THE SEPARATED PART OF THE PROXIMAL SHAFT HAD BENDING ON EACH SIDE. REGARDING THE BALLOON PART WAS NOT RUPTURED AND NO ABNORMALITIES FOUND. NO ABNORMALITIES WERE FOUND ON THE PRODUCTION RECORDS. IT IS CONSIDERED THAT THE REPORTED EVENT MAY HAVE BEEN CAUSED BY EXCESSIVE BENDING FORCE LOADED DURING THE OPERATION, 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. NO ADDITIONAL COMPLICATIONS HAVE BEEN REPORTED AND THE PATIENT IS IN GOOD CONDITION AFTER THE OPERATION. WE ARE REPORTING THIS EVENT BECAUSE WHEN THE CATHETER SHAFT SEPARATES IN THE BODY THAT POTENTIALLY CAUSE TO EMBOLISM OR HEMORRHAGIC COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BALLOON CATHETER SHAFT SNAPPED APART OCCURRED. THE BALLOON CATHETER USED FOR 90% STENOSIS LESION IN FROM LEFT MAIN TRUNK TO POSTERIOR LATERAL ARTERY. THE DOCTOR WAS RECOGNIZED THAT BLOOD OBSERVED INSIDE THE CATHETER SHAFT AFTER USED IT THREE TIMES, THEREFORE THE DOCTOR TRY TO WITHDRAW THE CATHETER BECAUSE THE DOCTOR SUSPECTED THE BALLOON RUPTURE OCCURRED. BUT THE BALLOON CATHETER SHAFT SNAPPED APART AND REMAIN THE PATIENT BODY DURING WITHDRAWN. SNAPPED PART OF THE CATHETER SHAFT WAS WITHDRAWN TOGETHER WITH THE GUIDEWIRE. THEN IT WAS REPLACED WITH A NEW IDENTICAL PRODUCT AND THE OPERATION WAS CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511489 APERTA NSE CORONARY DILATATION CATHETER Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring NWX GOODMAN CO., LTD. APN25013 ANH240319A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Hospitalization