BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 24272249 · Received February 5, 2026

    Report

    Report Number
    2124215-2026-06569
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    January 12, 2026
    Report Date
    March 30, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729783411
    PMA / PMN Number
    K121667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 PREMARKET / 501(K): K160823. DEVICE EVALUATION BY MFR: THE DEVICE WAS NOT RETURNED TO THE COMPLAINT INVESTIGATION SITE FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. THE REVIEW OF THE DHR IDENTIFIED THAT THERE WERE NO PROCESS RELATED NON-CONFORMANCES, SCRAP, OR REWORK PERFORMED DURING THE PRODUCTION THAT COULD EXPLAIN THE EVENT. THE REVIEWS ENSURE EACH DEVICE MEETS SPECIFICATION PRIOR TO RELEASE FOR USE. THERE IS NO INDICATION THE DEVICE MANUFACTURING PROCESS CONTRIBUTED TO THE EVENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO EVIDENCE THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELLED INDICATIONS. A RISK REVIEW WAS PERFORMED, AND IT CONFIRMED THAT THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. ONE POSSIBILITY IS THAT THE BALLOON BURST OCCURRED AS A RESULT OF AN UNINTENTIONAL HANDLING ERROR DURING REMOVAL OF THE DEVICE FROM ITS PACKAGING, GIVEN THAT THE BALLOON APPEARED ALREADY BURST UPON OPENING THE PACKAGE AND BEFORE ANY INFLATION ATTEMPTS WERE MADE. HOWEVER, AS THE DEVICE DID NOT RETURN FOR ANALYSIS THE REPORTED ALLEGATION CANNOT BE CONFIRMED. THIS INVESTIGATION IS ASSIGNED A MOST PROBABLE INVESTIGATION CONCLUSION CODE OF CAUSE NOT ESTABLISHED.

    Additional Manufacturer Narrative · 0

    G4 PREMARKET / 501(K): K160823.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. AN NC QUANTUM APEX 15 X 4.00MM WAS SELECTED FOR TREATMENT OF THE TARGET LESION. IT WAS DISCOVERED THAT THE BALLOON COULD NOT BE INFLATED AS THE BALLOON HAD ALREADY BURST. THE PROCEDURE WAS COMPLETED USING ANOTHER DIFFERENT DEVICE AND THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. AN NC QUANTUM APEX 15 X 4.00MM WAS SELECTED FOR TREATMENT OF THE TARGET LESION. IT WAS DISCOVERED THAT THE BALLOON COULD NOT BE INFLATED AS THE BALLOON HAD ALREADY BURST. THE PROCEDURE WAS COMPLETED USING ANOTHER DIFFERENT DEVICE AND THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330363 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493912415400 0036913816 08714729783411

    Patients

    Seq Age Sex Outcome Treatment
    1