BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 24506115 · Received March 4, 2026

    Report

    Report Number
    2124215-2026-11816
    Event Type
    Malfunction
    Date Received
    March 4, 2026
    Date of Event
    February 10, 2026
    Report Date
    March 31, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729783244
    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

    G4 PMA/510(K): K121667, K160823. INVESTIGATION RESULTS: MEDIA REVIEW: A DOCTORS NOTIFICATION LETTER WAS ATTACHED TO THE COMPLAINT RECORD. DEVICE ANALYSIS FINDINGS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD REVIEW: THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE 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 PRODUCT INVESTIGATION IS ASSIGNED THE MOST PROBABLE CAUSE CLASSIFICATION OF CAUSE NOT ESTABLISHED BASED ON THE LIMITED COMPLAINT INFORMATION AND THE FACT THAT NO DEVICE WAS RECEIVED FOR ANALYSIS. THIS CODE WAS SELECTED AS THE MOST PROBABLE COMPLAINT CAUSE BASED ON THE INFORMATION AVAILABLE AND THE INVESTIGATION CONDUCTED. IT IS POSSIBLE THAT AN INTERACTION OCCURRED WHEN ATTEMPTING TO LOAD THE GUIDEWIRE WHICH POTENTIALLY CAUSED THE GUIDEWIRE TO PUNCTURE THROUGH THE SHAFT. HOWEVER, BASED ON THE INFORMATION PROVIDED AND WITHOUT THE AVAILABILITY OF THE DEVICE FOR ANALYSIS A CLEAR CONCLUSION CANNOT BE ESTABLISHED.

    Additional Manufacturer Narrative · 0

    G4: PMA/510(K): K121667, K160823.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 12 X 2.50 MM NC QUANTUM APEX MR BALLOON CATHETER WAS SELECTED FOR USE. WHILE A WIRE WAS BEING ADVANCED THROUGH THE BALLOON, A HOLE BETWEEN THE IN AND EXIT PORT WAS OBSERVED, THROUGH WHICH THE GUIDEWIRE WAS EXITING. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 12 X 2.50 MM NC QUANTUM APEX MR BALLOON CATHETER WAS SELECTED FOR USE. WHILE A WIRE WAS BEING ADVANCED THROUGH THE BALLOON, A HOLE BETWEEN THE IN AND EXIT PORT WAS OBSERVED, THROUGH WHICH THE GUIDEWIRE WAS EXITING. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186691 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493912412250 0036717933 08714729783244

    Patients

    Seq Age Sex Outcome Treatment
    1