BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APERTA NSE PTA BALLOON DILATATION CATHETER

    MDR report key: 22563428 · Received July 22, 2025

    Report

    Report Number
    3007835716-2025-00079
    Event Type
    Injury
    Date Received
    July 22, 2025
    Date of Event
    August 31, 2024
    Manufacturer
    GOODMAN CO., LTD.
    Product Code
    PNO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION IS NOT COMPLETED YET, THEREFORE WE DID NOT DETERMINE THAT CAUSE OF THIS EVENT. THIS IS AN INITIAL REPORT, INVESTIGATION RESULT WILL BE DESCRIBED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION, AND THE INVESTIGATION WAS UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED PROBLEM. NO ABNORMALITIES WERE FOUND ON THE PRODUCTION RECORDS. THE BIOLOGICAL SAFETY OF THE PRODUCT IN QUESTION HAS BEEN CONFIRMED THROUGH EVALUATION TESTING, AND IT HAS BEEN CONFIRMED THAT THE STERILIZATION PROCESS WAS PROPERLY MANAGED. THE RESULTS OF THE INVESTIGATION SUGGEST THAT THE PRODUCT IS UNLIKELY TO CAUSE AN ALLERGIC REACTION, BUT AS THE ACTUAL PRODUCT WAS NOT PROVIDED AND AN ON-SITE INSPECTION WAS NOT POSSIBLE, THE CAUSE HAS NOT IDENTIFIED. NO ADDITIONAL COMPLICATIONS HAVE BEEN REPORTED, AND THE PATIENT'S POSTOPERATIVE CONDITION IS GOOD. THE INSTRUCTIONS FOR USE (IFU) CONTAIN INFORMATION ON GENERAL USAGE, WARNINGS AND PRECAUTIONS RELATED TO THE DEVICE, AND POTENTIAL COMPLICATIONS AND OTHER EVENTS SIMILAR TO THIS EVENT. THIS REPORT DOES NOT IMPLY THAT ANYONE HAS ACKNOWLEDGED THAT THE PRODUCT DESCRIBED IN THIS REPORT IS DEFECTIVE.

    Description of Event or Problem · 0

    THERE HAS BEEN A REPORT OF A CASE SUSPECTED TO EXHIBIT ALLERGIC SYMPTOMS. DURING THE SEQUENTIAL DILATION OF THE STENOTIC LESION, THE PATIENT DEVELOPED ITCHING AND WHEALS ON BOTH THIGHS. IMMEDIATELY AFTER THE PROCEDURE, THE PATIENT WAS OBSERVED TO HAVE ITCHING AND WHEALS ON THE UPPER AND LOWER LIMBS, ABDOMEN, BACK, AND BUTTOCKS. THEN ANTI ALLERGIC DRUGS WAS ADMINISTERED, AFTER THAT THE PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1713346 APERTA NSE PTA BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS, CUTTING/SCORING PNO GOODMAN CO., LTD. AA18-05050040 ALDD24C003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other