BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 22998437 · Received September 8, 2025

    Report

    Report Number
    2124215-2025-62989
    Event Type
    Malfunction
    Date Received
    September 8, 2025
    Date of Event
    August 15, 2025
    Report Date
    April 9, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729783206
    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 PREMARKET / 510(K): K160823.

    Additional Manufacturer Narrative · 0

    G4 PREMARKET / 510(K): K160823 INVESTIGATION RESULTS: DEVICE ANALYSIS FINDINGS: THE 8MM X 4.50MM NC QUANTUM APEX MR BALLOON CATHETER WAS RETURNED FOR ANALYSIS. A VISUAL AND TACTILE EXAMINATION IDENTIFIED NO ISSUES ALONG THE LENGTH OF THE HYPOTUBE SHAFT. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND INNER LUMEN AND MID-SHAFT SECTION FOUND NO ISSUES. A DETAILED MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL IDENTIFIED AN 8MM LONGITUDINAL TEAR ACROSS THE MAIN BODY OF THE BALLOON. THE DISTAL BUMPER TIP WAS DEFORMED. A MICROSCOPIC EXAMINATION OF THE PROXIMAL AND DISTAL MARKERBANDS IDENTIFIED NO DAMAGE. A LEAKAGE TEST WAS PERFORMED; HOWEVER, THE BALLOON COULD NOT BE INFLATED DUE TO AN 8MM LONGITUDINAL TEAR ACROSS THE MAIN BODY OF THE BALLOON. NO OTHER DEVICE ISSUES WERE IDENTIFIED DURING RETURNED PRODUCT ANALYSIS. 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 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 AND THE INVESTIGATION CONDUCTED. IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. DEVICE ANALYSIS IDENTIFIED AN 8MM LONGITUDINAL TEAR ACROSS THE MAIN BODY OF THE BALLOON AND THEREFORE CONFIRMING THE ALLEGED MATERIAL RUPTURE. IN ADDITION, THE DISTAL BUMPER TIP WAS DEFORMED. BASED ON THE EVENT DETAILS, IT IS POSSIBLE INTERACTIONS OF THE BALLOON WITH THE LESION'S ANATOMICAL FEATURES, AS WELL AS INTERACTIONS WITH OTHER ANCILLARY DEVICES USED DURING THE PROCEDURE LED TO THE MATERIAL RUPTURE AND TIP DAMAGE. HOWEVER, BASED ON THE AVAILABLE COMPLAINT INFORMATION AND CONDITION OF THE RETURNED DEVICE, A CLEAR CONCLUSION CANNOT BE ESTABLISHED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH DOUBLE VESSEL DISEASE AND UNDERWENT PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA). THE CHRONIC TOTALLY OCCLUDED TARGET LESIONS WERE LOCATED IN THE RIGHT CORONARY ARTERY (RCA) AND LEFT MAIN TO LEFT ANTERIOR DESCENDING ARTERY (LMLAD). AFTER SUCCESSFUL RCA INTERVENTION, PTCA TO LMLAD WAS PERFORMED UNDER INTRAVASCULAR ULTRASOUND (IVUS) GUIDANCE BY INSERTING 7F NON-BOSTON SCIENTIFIC (BSC) GUIDE CATHETER. THE LESION WAS CROSSED WITH A NON-BSC GUIDEWIRE, AND IVUS EVALUATION WAS DONE FOLLOWED BY STENTING IN THE LMLAD. AN 8MM X 4.50MM NC QUANTUM APEX? BALLOON CATHETER WAS ADVANCED FOR POST DILATION. HOWEVER, ON THE FIRST INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH DOUBLE VESSEL DISEASE AND UNDERWENT PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA). THE CHRONIC TOTALLY OCCLUDED TARGET LESIONS WERE LOCATED IN THE RIGHT CORONARY ARTERY (RCA) AND LEFT MAIN TO LEFT ANTERIOR DESCENDING ARTERY (LMLAD). AFTER SUCCESSFUL RCA INTERVENTION, PTCA TO LMLAD WAS PERFORMED UNDER INTRAVASCULAR ULTRASOUND (IVUS) GUIDANCE BY INSERTING 7F NON-BOSTON SCIENTIFIC (BSC) GUIDE CATHETER. THE LESION WAS CROSSED WITH A NON-BSC GUIDEWIRE, AND IVUS EVALUATION WAS DONE FOLLOWED BY STENTING IN THE LMLAD. AN 8MM X 4.50MM NC QUANTUM APEX? BALLOON CATHETER WAS ADVANCED FOR POST DILATION. HOWEVER, ON THE FIRST INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2068666 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493912408450 0035793452 08714729783206

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male