BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX

    MDR report key: 21689526 · Received March 25, 2025

    Report

    Report Number
    2124215-2025-16076
    Event Type
    Malfunction
    Date Received
    March 25, 2025
    Date of Event
    March 1, 2025
    Report Date
    December 22, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729783138
    PMA / PMN Number
    K121667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT: USED FIRST DATE OF THE MONTH SINCE EXACT DATE OF EVENT WAS NOT PROVIDED. G4 PREMARKET / 510(K): K121667, K160823. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT: USED FIRST DATE OF THE MONTH SINCE EXACT DATE OF EVENT WAS NOT PROVIDED. G4 PREMARKET / 510(K): K121667, K160823. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED. NC QUANTUM APEX MR 8MM X 2.50MM WAS RETURNED FOR ANALYSIS. THE DEVICE WAS RECEIVED INSIDE ITS OPENED, DAMAGED OUTER BOX. THE BOX WAS CREASED AND DENTED. THE STERILE INNER POUCH WAS NOT RETURNED FOR ANALYSIS. THE DEVICE WAS RECEIVED IN THREE SECTIONS DUE TO TWO BREAKS IN THE HYPOTUBE SHAFT. ONE BREAK WAS LOCATED AT 39.1CM DISTAL TO THE DISTAL END OF THE STRAIN RELIEF, AND THE OTHER BREAK WAS LOCATED AT 73.7CM PROXIMAL FROM THE TIP. A MIDDLE SECTION OF HYPOTUBE MEASURING 28CM IN LENGTH, WAS ALSO RECEIVED AND THIS SECTION WAS KINKED IN MULTIPLE LOCATIONS. NO KINKS OR DAMAGES. MICROSCOPIC ANALYSIS REVEALED NO DAMAGE WAS IDENTIFIED DURING A MICROSCOPIC EXAMINATION OF THE EXTRUSION SHAFT. THERE WAS TRACES OF WHAT APPEARS TO BE BLOOD INSIDE THE INNER LUMEN. A DETAILED MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL IDENTIFIED NO DAMAGES. THE BALLOON WAS FOLDED. A MICROSCOPIC EXAMINATION OF THE TIP SECTION FOUND NO DAMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. A 8MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE IT WAS NOTED THAT THE DEVICE WAS CONTAMINATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. A 8MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE IT WAS NOTED THAT THE DEVICE WAS CONTAMINATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121299 NC QUANTUM APEX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493912408250 0024695365 08714729783138

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown