BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX

    MDR report key: 21610213 · Received March 14, 2025

    Report

    Report Number
    2124215-2025-16056
    Event Type
    Malfunction
    Date Received
    March 14, 2025
    Date of Event
    January 30, 2025
    Report Date
    December 1, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729783398
    PMA / PMN Number
    K121667
    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). 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

    E1: INITIAL REPORTER ADDRESS 1: (B)(6). GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED. G4: PREMARKET / 510(K) #: K121667, K160823. DEVICE EVALUATED BY MFR. : NC QUANTUM APEX MR 15MM X 3.50MM WAS RETURNED FOR ANALYSIS. VISUAL AND TACTILE INSPECTION REVEALED NO ISSUES WITH THE HYPOTUBE SHAFT. A VISUAL INSPECTION OF THE OUTER AND INNER LUMEN AND TACTILE EXAMINATION OF THE ENTIRE EXTRUSION FOUND NO ISSUES. A DETAILED MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL IDENTIFIED A LONGITUDINAL TEAR IN THE DISTAL SECTION. BUMPER TIP SHOWED NO SIGNS OF DISTAL TIP DAMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX CORONARY ARTERY. PHYSICIAN PRE-DILATED WITH A 2.0 SC BALLOON THEN TOOK A 15MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER. HOWEVER, THE BALLOON GOT BURST AT 11 ATMOSPHERES DUE TO CALCIFICATION. THE PROCEDURE WAS COMPLETED VIA ALTERNATIVE METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX CORONARY ARTERY. PHYSICIAN PRE-DILATED WITH A 2.0 SC BALLOON THEN TOOK A 15MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER. HOWEVER, THE BALLOON GOT BURST AT 11 ATMOSPHERES DUE TO CALCIFICATION. THE PROCEDURE WAS COMPLETED VIA ALTERNATIVE METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900260 NC QUANTUM APEX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493912415350 0034094220 08714729783398

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown