BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APERTA NSE CORONARY DILATATION CATHETER

    MDR report key: 24868156 · Received April 14, 2026

    Report

    Report Number
    3007835716-2026-00037
    Event Type
    Injury
    Date Received
    April 14, 2026
    Date of Event
    March 17, 2026
    Manufacturer
    NIPRO VASCULAR CORPORATION
    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. WE CONFIRMED THAT THE MID-SHAFT OF THE PRODUCT HAD ELONGATED AND WAS SEVERED. NO ABNORMALITIES WERE FOUND ON THE PRODUCTION RECORDS. THE REPORTED INCIDENT IS THOUGHT TO HAVE OCCURRED WHEN THE PRODUCT BECAME STUCK DURING REMOVAL DUE TO LOCALIZED CONTACT WITH A HARD PART OR THE INFLUENCE OF OTHER DEVICES USED IN CONJUNCTION WITH IT. CONTINUING THE REMOVAL OPERATION IN THIS STATE RESULTED IN EXCESSIVE TENSILE STRESS BEING APPLIED TO THE SHAFT, LEADING TO BREAKAGE. HOWEVER, 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 USERS 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. WE ARE REPORTING THIS EVENT BECAUSE SEPARATION OF THE PART OF THE CATHETER DURING OPERATION IN THE PATIENT BODY THAT CAN LEAD TO EMBOLISM BY IT REMAIN IN THE BODY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SHAFT OF A BALLOON CATHETER FRACTURED. THE CATHETER WAS USED TO TREAT A SEVERELY CALCIFIED LESION IN THE RCA. THE PATIENT HAD PREVIOUSLY UNDERGONE PCI WITH STENT IMPLANTATION IN THE DISTAL RCA #1. THE BALLOON WAS USED IN CONJUNCTION WITH A GUIDE EXTENSION CATHETER; HOWEVER, ADVANCEMENT OF THE BALLOON THROUGH THE LESION AT RCA #1 WAS DIFFICULT. THEREFORE, BALLOON DILATION WAS PERFORMED WITH FORWARD PRESSURE, ALLOWING THE BALLOON TO BE ADVANCED AND DILATED UP TO RCA #3. SUBSEQUENTLY, WHEN REMOVAL OF THE DEVICE WAS ATTEMPTED, MARKED RESISTANCE WAS ENCOUNTERED. UPON WITHDRAWAL, THE SHAFT OF THE BALLOON CATHETER FRACTURED, AND A PORTION OF THE DEVICE REMAINED INTRAVASCULAR. RETRIEVAL OF THE RETAINED FRAGMENT WAS ATTEMPTED USING A SNARE CATHETER, BUT RETRIEVAL WAS UNSUCCESSFUL. THEREAFTER, A GUIDEWIRE WAS ADVANCED ALONGSIDE THE RETAINED BALLOON, AND DILATION WITH ANOTHER BALLOON CATHETER WAS ATTEMPTED; HOWEVER, THE DEVICE COULD NOT BE RELEASED. DURING THE PROCEDURE, NO CHANGES IN THE PATIENT'S CLINICAL CONDITION WERE OBSERVED. COLLATERAL CIRCULATION FROM THE LEFT CORONARY ARTERY WAS CONFIRMED, AND HEMODYNAMIC STABILITY WAS MAINTAINED. THEREFORE, NO ADDITIONAL INTERVENTIONAL PROCEDURES WERE PERFORMED. NO ADDITIONAL COMPLICATIONS HAVE BEEN REPORTED AND THE PATIENT IS IN GOOD CONDITION AFTER THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101042 APERTA NSE CORONARY DILATATION CATHETER Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring NWX NIPRO VASCULAR CORPORATION APN32513 ANH250711E

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention