BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QDOT MICRO

    MDR report key: 18914484 · Received March 15, 2024

    Report

    Report Number
    2029046-2024-00854
    Event Type
    Injury
    Date Received
    March 15, 2024
    Date of Event
    December 28, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835016710
    PMA / PMN Number
    P210027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KOBZA R, HILFIKER G, RISSOTTO S, MAHIDA S, GREBMER C, DURU F, PÜRERFELLNER H, BERTE B. PERFORMANCE AND SAFETY OF TEMPERATURE- AND FLOW-CONTROLLED RADIOFREQUENCY ABLATION FOR VENTRICULAR ARRHYTHMIA. EUROPACE. 2023 DEC 28;26(1):EUAD372. DOI: 10.1093/EUROPACE/EUAD372. PMID: 38193796; PMCID: PMC10775682. 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 NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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 REF #: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KOBZA R, HILFIKER G, RISSOTTO S, MAHIDA S, GREBMER C, DURU F, PÜRERFELLNER H, BERTE B. PERFORMANCE AND SAFETY OF TEMPERATURE- AND FLOW-CONTROLLED RADIOFREQUENCY ABLATION FOR VENTRICULAR ARRHYTHMIA. EUROPACE. 2023 DEC 28;26(1):EUAD372. DOI: 10.1093/EUROPACE/EUAD372. PMID: 38193796; PMCID: PMC10775682. OBJECTIVE/METHODS/STUDY DATA: AIMS: HIGH-POWER ABLATION IS EFFECTIVE FOR VENTRICULAR ARRHYTHMIA ABLATION; HOWEVER, IT INCREASES THE RISK OF STEAM POPS. THE AIM OF THIS STUDY WAS TO DEFINE THE SAFETY AND EFFICACY OF QMODE ABLATION IN THE VENTRICLE AND THE RISK OF STEAM POP. METHODS AND RESULTS: CONSECUTIVE PATIENTS UNDERGOING VENTRICULAR ABLATION USING QDOT WERE INCLUDED IN A PROSPECTIVE SINGLE-CENTRE REGISTRY. PROCEDURAL DATA, COMPLICATIONS, AND FOLLOW-UP WERE SYSTEMATICALLY ANALYSED AND COMPARED WITH A HISTORICAL VENTRICULAR TACHYCARDIA (VT) AND PREMATURE VENTRICULAR COMPLEXES (PVC) COHORT ABLATED USING STSF. QMODE (=50 W) ABLATION WAS PERFORMED IN 107 PATIENTS [AGE 62 ± 13 YEARS; 76% MALE; VT (N = 41); PVC (N = 66)]. A TOTAL OF 2456 APPLICATIONS WERE ANALYSED [POWER: 45.9 ± 5.0 W WITH MINIMAL POWER TITRATION (90% > 95% MAX POWER); DURATION 26 ± 8 S; IMPEDANCE DROP 9.4 ± 4.7 O; ABLATION INDEX: 569 ± 163; MEAN-MAX TEMPERATURE 44.3 ± 2.6°C]. VENTRICULAR TACHYCARDIA ABLATION WAS ASSOCIATED WITH SHORTER RADIOFREQUENCY (RF) TIME AND A TREND TOWARDS SHORTER PROCEDURE TIMES USING QDOT (QDOT VS. STSF: 20.1 ± 14.7 VS. 31 ± 17 MIN; P = 0.002, 151 ± 59 VS. 172 ± 48 MIN; P = 0.06). COMPLICATIONS, VT RECURRENCE, AND MORTALITY RATES WERE COMPARABLE (QDOT VS. STSF: 2% VS. 2%; P = 0.9, 24% VS. 27%; P = 0.82, AND 2% VS. 4%; P = 0.67). FIVE AUDIBLE STEAM POPS (0.02%) OCCURRED. PREMATURE VENTRICULAR COMPLEX ABLATION WAS ASSOCIATED WITH COMPARABLE RF AND PROCEDURE TIMES (QDOT VS. STSF: 4.8 ± 4.6 VS. 3.9 ± 3.1 MIN; P = 0.25 AND 96.1 ± 31.9 VS. 94.6 ± 24.7 MIN; P = 0.75). COMPLICATION AND PVC RECURRENCE WERE ALSO COMPARABLE (QDOT VS. STSF: 0% VS. 3%; P = 0.17 AND 19% VS. 22%; P = 0.71). CONCLUSION: VENTRICULAR ABLATION USING QMODE = 50 W IS SAFE AND EFFECTIVE FOR BOTH VT AND PVC ABLATION AND IS ASSOCIATED WITH A LOW RISK FOR STEAM POP. THE DEATHS NOTED IN ARTICLE WERE NOTED IN FOLLOW-UP ONLY AND NOT RELATED TO PROCEDURE. THIS STUDY CAPTURED OUTCOMES WITH QDOT BUT RESULTS WERE COMPARED TO A GROUP BASED UPON REGISTRY THAT USED SMARTTOUCH SF ABLATION CATHETER. HOWEVER, THE ARTICLE DOES NOT DETAIL THE COMPLICATIONS FOR THE STSF GROUP. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: QDOT ABLATION CATHETER CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE USED IN THIS STUDY: CARTO SYSTEM, PREFACE SHEATH, PENTARAY MAPPING CATHETER, OCTARAY MAPPING CATHETER NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED QDOT ABLATION CATHETER: QTY 1 CATHETER ENTRAPPED IN MITRAL VALVE APPARATUS AND RETRACTED USING CONSTANT TENSION, 30 ML IRRIGATION AND A QMODE ABLATION PLUS 90W ABLATION (MEDICAL DEVICE ENTRAPMENT-EXCESSIVE MANIPULATION REQUIRED) THIS RESULTED IN MODERATE MITRAL REGURGITATION (HEART VALVE INCOMPETENCE)(SERIOUS INJURY) POST PROCEDURE WITHOUT EVIDENCE OF A FLAIL LEAFLET QTY 1 PERICARDIAL TAMPONADE (CARDIAC TAMPONADE) REQUIRING PERCUTANEOUS DRAINAGE (RECOGNIZED PROCEDURAL COMPLICATION) QTY 5 AUDIBLE (STEAM POP)S WITH DETAILS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875456 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 10846835016710

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R UNK_CARTO 3| UNK_OCTARAY NAV| UNK_PENTARAY| UNK_PREFACE SHEATH