BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QDOT MICRO

    MDR report key: 23256251 · Received October 9, 2025

    Report

    Report Number
    2029046-2025-03407
    Event Type
    Injury
    Date Received
    October 9, 2025
    Report Date
    October 8, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    PMA / PMN Number
    P210027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: MODI VA, DHORE-PATIL A, VALDERRABANO M, LIN CH, NAGUEH SF, KHAN M, LAZZARA G, CHANG SM, SHAH DJ. IATROGENIC VENTRICULAR SEPTAL DEFECT FOLLOWING SIMPLE PVC ABLATION: A CASE OF DELAYED PERCUTANEOUS CLOSURE. JACC CASE REP. 2025 JUL 30;30(21):104435. DOI: 10.1016/J.JACCAS.2025.104435. PMID: 40750175. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. H6 HEALTH EFFECT - CLINICAL CODE OF APPROPRIATE TERM / CODE NOT AVAILABLE (E2402) IS USED TO REPRESENT INJURY (E20) THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: MODI VA, DHORE-PATIL A, VALDERRABANO M, LIN CH, NAGUEH SF, KHAN M, LAZZARA G, CHANG SM, SHAH DJ. IATROGENIC VENTRICULAR SEPTAL DEFECT FOLLOWING SIMPLE PVC ABLATION: A CASE OF DELAYED PERCUTANEOUS CLOSURE. JACC CASE REP. 2025 JUL 30;30(21):104435. DOI: 10.1016/J.JACCAS.2025.104435. PMID: 40750175. BACKGROUND AND PURPOSE: IATROGENIC MUSCULAR VENTRICULAR SEPTAL DEFECT (VSD) IS A RARE BUT SERIOUS COMPLICATION OF PREMATURE VENTRICULAR COMPLEX (PVC) ABLATION. TIMELY DIAGNOSIS AND MANAGEMENT ARE ESSENTIAL. THE STUDY AIMED TO DOCUMENT A RARE CASE OF AN IATROGENIC MUSCULAR VSD THAT DEVELOPED AFTER RF ABLATION OF PARAHISIAN PVCS AND SHOW HOW PERCUTANEOUS DEVICE CLOSURE PROVIDED A SAFE AND EFFECTIVE SOLUTION. CASE SUMMARY: A 77-YEAR-OLD WOMAN UNDERWENT RADIOFREQUENCY ABLATION FOR SYMPTOMATIC PARAHISIAN PVCS. RADIOFREQUENCY APPLICATIONS UP TO 20 W FOR 30 SECONDS WERE USED. FOLLOWING ABLATION SHE PRESENTED WITH WORSENING HEART FAILURE SYMPTOMS. MULTIMODAL IMAGING CONFIRMED A HEMODYNAMICALLY SIGNIFICANT IRREGULAR VSD MEASURING APPROXIMATELY 11 × 8 MM AT THE ABLATION SITE. GIVEN HER HIGH SURGICAL RISK, SUCCESSFUL DELAYED PERCUTANEOUS CLOSURE WAS PERFORMED USING AN AMPLATZER 12-MM MUSCULAR VSD OCCLUDER LEADING TO RESOLUTION OF SYMPTOMS. DISCUSSION: PVC ABLATION REQUIRES CAREFUL PATIENT SELECTION, PARTICULARLY WHEN TARGETING HIGH-RISK ANATOMY. IATROGENIC VSD REQUIRES EARLY RECOGNITION AND INDIVIDUALIZED MANAGEMENT. MULTIMODAL IMAGING IS HELPFUL IN DIAGNOSIS AND GUIDING MANAGEMENT. PERCUTANEOUS CLOSURE MAY BE AN EFFECTIVE ALTERNATIVE TO SURGICAL CLOSURE. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICES ARE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: QDOT MICRO CATHETER. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR UNK_QDOT MICRO: - 77-YEAR-OLD WOMAN, EXPERIENCED PROGRESSIVELY WORSENING SHORTNESS OF BREATH AND FATIGUE, FOR WHICH SHE WAS ADMITTED TO THE HOSPITAL 1 MONTH AFTER THE ABLATION. IATROGENIC MUSCULAR VENTRICULAR SEPTAL DEFECT (VSD) WAS REPORTED. PERCUTANEOUS CLOSURE WAS PERFORMED USING AN AMPLATZER 12-MM MUSCULAR VSD OCCLUDER LEADING TO RESOLUTION OF SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2512914 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R| H