BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_QDOT MICRO

    MDR report key: 17612686 · Received August 24, 2023

    Report

    Report Number
    2029046-2023-01854
    Event Type
    Injury
    Date Received
    August 24, 2023
    Date of Event
    August 23, 2022
    Report Date
    August 24, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    PMA / PMN Number
    P210027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED LATE DUE TO A RETROSPECTIVE REVIEW OF COMPLAINTS FOR THE QDOT MICRO PRODUCTS. BIOSENSE WEBSTER¿S INVESTIGATION DETERMINED THAT UPON APPROVAL OF QDOT IN THE UNITED STATES ON NOVEMBER 23, 2022, THE ELECTRONIC COMPLAINTS SYSTEM WAS NOT UPDATED AND THEREFORE MEDICAL DEVICE REPORTS WERE NOT SUBMITTED IN A TIMELY MANNER. THROUGH BIOSENSE WEBSTER¿S INVESTIGATION IT WAS DETERMINED THAT THIS WAS AN ISOLATED CASE. AN INTERNAL ACTION WAS OPENED TO ADDRESS THIS ISSUE. THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: CHU G, CALVERT P, SIDHU B, MAVILAKANDY A, KOTB A, TOVMASSIAN L, KOZHUHAROV N, BIERMÉ C, DENHAM N, PIUS C, O'BRIEN J, DING WY, LUTHER V, SNOWDON RL, NG GA, GUPTA D. PATIENT EXPERIENCE OF VERY HIGH POWER SHORT DURATION RADIOFREQUENCY ABLATION FOR ATRIAL FIBRILLATION UNDER MILD CONSCIOUS SEDATION. J INTERV CARD ELECTROPHYSIOL. 2023 MAR;66(2):445-453. DOI: 10.1007/S10840-022-01351-5. EPUB 2022 AUG 23. PMID: 35997848; PMCID: PMC9396586. NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS PROVIDED BY THE CUSTOMER. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. 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. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: CHU G, CALVERT P, SIDHU B, MAVILAKANDY A, KOTB A, TOVMASSIAN L, KOZHUHAROV N, BIERMÉ C, DENHAM N, PIUS C, O'BRIEN J, DING WY, LUTHER V, SNOWDON RL, NG GA, GUPTA D. PATIENT EXPERIENCE OF VERY HIGH POWER SHORT DURATION RADIOFREQUENCY ABLATION FOR ATRIAL FIBRILLATION UNDER MILD CONSCIOUS SEDATION. J INTERV CARD ELECTROPHYSIOL. 2023 MAR;66(2):445-453. DOI: 10.1007/S10840-022-01351-5. EPUB 2022 AUG 23. PMID: 35997848; PMCID: PMC9396586. OBJECTIVE/METHODS/STUDY DATA: LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: QDOT MICRO ABLATION CATHETER OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: ARCTIC FRONT ADVANCE PRO CRYO ABLATION CATHETER (MEDTRONIC); POLAR X CRYO ABLATION CATHETER (BOSTON SCIENTIFC) EXACT QUANTITIES OF PRODUCTS CANNOT BE ACCURATELY DETERMINED AS PATIENTS CAN EXPERIENCE MORE THAN ADVERSE EVENT AND THE DATA IS SUMMARIZED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK_QDOT MICRO QTY 2 TRANSIENT SIGNS OR SYMPTOMS OF ONE GLOBAL AMNESIA AND ONE DYSPHAGIA (TRANSIENT ISCHEMIC ATTACK) MANAGED CONSERVATIVELY (MINOR INJURY) AND RESOLVED. QTY 2 (CARDIAC TAMPONADE) THAT REQUIRED PERICARDIOCENTESIS (RECOGNIZED PROCEDURAL COMPLICATION) THAT RESOLVED. QTY 1 CHEST INFECTION (INFECTION) MANAGED WITH ANTIBIOTIC THERAPY (MINOR INJURY) THAT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925911 UNK_QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| L ARCTIC FRONT ADV PRO CRYO ABLATION CATH(MEDTRONIC)| OLAR X CRYO ABLATION CATHETER (BOSTON SCIENTIFC)