BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 25116438 · Received May 7, 2026

    Report

    Report Number
    2124215-2026-24861
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    January 24, 2026
    Report Date
    May 7, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729783176
    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). E1: INITIAL REPORTER CITY: (B)(6). G4: PREMARKET / 510(K) #: K160823. INVESTIGATION RESULTS: DEVICE ANALYSIS FINDINGS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS CANNOT BE PERFORMED. DEVICE HISTORY RECORD (DHR) REVIEW: IT WAS CONFIRMED THAT THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW: REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. RISK REVIEW: A RISK REVIEW WAS PERFORMED, AND IT CONFIRMED THAT THE EVENT WAS DEFINED IN THE RISK DOCUMENTATION AND IS RECORDED ACCORDINGLY IN THE PRODUCT RECORD REVIEW. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION: THIS INVESTIGATION IS ASSIGNED A MOST PROBABLE INVESTIGATION CONCLUSION CODE OF CAUSE NOT ESTABLISHED. THIS CODE WAS SELECTED AS THE MOST PROBABLE COMPLAINT CAUSE BASED ON THE INFORMATION AVAILABLE. BASED ON THE LIMITED COMPLAINT INFORMATION AND THE FACT THAT NO DEVICE WAS RECEIVED FOR ANALYSIS, IT IS NOT POSSIBLE TO ESTABLISH WHAT THE CAUSE OF THE COMPLAINT WAS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT WAS UNDERGOING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. AFTER A 6F NON-BOSTON SCIENTIFIC (BSC) GUIDE CATHETER WAS ENGAGED COAXIALLY AND A NON-BSC GUIDEWIRE WAS CROSSED THE LESION, PRE-DILATION WAS PERFORMED WITH 2.50 X 15MM SEMI COMPLIANT BALLOON CATHETER. A 3.00 X 32MM SYNERGY SHIELD DRUG-ELUTING STENT WAS ADVANCED AND DEPLOYED. POST-DEPLOYMENT, AN 8MM X 3.50MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION. HOWEVER, WHILE LOADING ON WIRE, THE SHAFT WAS BROKEN. ANOTHER 3.50MM X 8MM NC BALLOON CATHETER WAS USED TO POST-DILATE THE LESION AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192180 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493912408350 0037081171 08714729783176

    Patients

    Seq Age Sex Outcome Treatment
    1