BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX

    MDR report key: 24793855 · Received April 6, 2026

    Report

    Report Number
    2124215-2026-18621
    Event Type
    Malfunction
    Date Received
    April 6, 2026
    Date of Event
    March 16, 2026
    Report Date
    April 6, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729783466
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER ADDRESS 1: (B)(6). G4: PMA/510(K) # FIELD ON 3500A FORM: K121667, K160823.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATERIAL WAS PRESENT IN THE DEVICE OCCURRED. A 20MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, WHILE OPENING THE STERILE PACK, A FOREIGN PARTICLE (STRAND OF HAIR) WAS FOUND INSIDE THE PACKAGING PRIOR TO USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854953 NC QUANTUM APEX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493912420250 0037687471 08714729783466

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown