BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_QDOT MICRO

    MDR report key: 14658698 · Received June 10, 2022

    Report

    Report Number
    2029046-2022-01266
    Event Type
    Injury
    Date Received
    June 10, 2022
    Date of Event
    April 1, 2022
    Report Date
    June 10, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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: BORTONE A, ALBENQUE JP, RAMIREZ FD, HAÏSSAGUERRE M, COMBES S, CONSTANTIN M, LABORIE G, BRAULT-NOBLE G, MARIJON É, JAÏS P, PAMBRUN T. 90 VS 50-WATT RADIOFREQUENCY APPLICATIONS FOR PULMONARY VEIN ISOLATION: EXPERIMENTAL AND CLINICAL FINDINGS. CIRC ARRHYTHM ELECTROPHYSIOL. 2022 APR;15(4):E010663. DOI: 10.1161/CIRCEP.121.010663. EPUB 2022 APR 1. PMID: 35363039. 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. 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: BORTONE A, ALBENQUE JP, RAMIREZ FD, HAÏSSAGUERRE M, COMBES S, CONSTANTIN M, LABORIE G, BRAULT-NOBLE G, MARIJON É, JAÏS P, PAMBRUN T. 90 VS 50-WATT RADIOFREQUENCY APPLICATIONS FOR PULMONARY VEIN ISOLATION: EXPERIMENTAL AND CLINICAL FINDINGS. CIRC ARRHYTHM ELECTROPHYSIOL. 2022 APR;15(4):E010663. DOI: 10.1161/CIRCEP.121.010663. EPUB 2022 APR 1. PMID: 35363039. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND: FIFTY-WATT RADIOFREQUENCY APPLICATIONS HAVE PROVEN TO BE SAFE AND EFFICIENT FOR PULMONARY VEIN ISOLATION (PVI). HOWEVER, AS PV RECONNECTION STILL OCCURS AND ABLATION CATHETER INSTABILITY SIGNIFICANTLY CONTRIBUTES TO SUBOPTIMAL LESION FORMATION, A NEW ABLATION CATHETER CAPABLE OF DELIVERING 90 W FOR 4 SECONDS ONLY HAS BEEN DEVELOPED WITH THE AIM OF IMPROVING PVI OUTCOMES. IN THIS SETTING, WE SOUGHT TO DETERMINE WHETHER 90 W APPLICATIONS CREATE TRANSMURAL LESIONS WITHOUT COLLATERAL DAMAGE EXPERIMENTALLY AND WHETHER THEY CAN SAFELY IMPROVE PVI PROCEDURES CLINICALLY COMPARED WITH 50 W SETTINGS. METHODS: EXPERIMENTALLY, INDIVIDUAL LESIONS WERE CREATED IN VIVO IN THE RIGHT ATRIUM OF 6 SWINE WITH 90 W-4 SECONDS APPLICATIONS USING THE SMARTTOUCH-SF CATHETER IN A POWER-CONTROLLED MODE (3 ANIMALS) OR THE QDOT-MICRO CATHETER IN A TEMPERATURE CONTROLLED MODE (3 ANIMALS). CLINICALLY, PVI WAS PERFORMED IN A HOMOGENOUS POPULATION OF 150 CONSECUTIVE PAROXYSMAL ATRIAL FIBRILLATION PATIENTS USING CARTO AND THE QDOT-MICRO CATHETER IN A TEMPERATURE-CONTROLLED MODE (75 PATIENTS 50 W-ABLATION INDEX-GUIDED AND 75 PATIENTS 90 W-4 SECONDS). RESULTS: MOSTLY, (94.9%) EXPERIMENTAL LESIONS WERE TRANSMURAL IN THE THIN-WALLED RIGHT ATRIUM OF SWINE. HOWEVER, COLLATERAL DAMAGE WAS OBSERVED WITH BOTH CATHETERS IN 17.9% OF LESIONS. CLINICALLY, 90 W PROCEDURES HAD A LOWER FIRST-PASS PVI RATE (49% VERSUS 81%, P<10-4) AND A HIGHER ACUTE PV RECONNECTION RATE (21% VERSUS 5%, P=0.004) THAN 50 W PROCEDURES, WHEREAS TOTAL PROCEDURAL DURATION (62 VERSUS 66 MINUTES, P=0.09), 1-YEAR SINUS RHYTHM MAINTENANCE (88% VERSUS 90%, P=0.6) AND SAFETY (1 TAMPONADE PER GROUP) WERE SIMILAR IN BOTH GROUPS. CONCLUSIONS: EXPERIMENTALLY, USING THE QDOT-MICRO CATHETER, 90 W-4 SECONDS LESIONS ARE MOSTLY TRANSMURAL IN THE THIN WALLED RIGHT ATRIUM OF SWINE (MEDIAN DEPTH 1.87 MM) WITH A MODERATE LESION DIAMETER OF 6.62 MM BUT RETAIN THE POTENTIAL FOR COLLATERAL DAMAGE. CLINICALLY, 90 W-4 SECONDS APPLICATIONS ARE ASSOCIATED WITH A LOWER FIRST-PASS PVI RATE AND A HIGHER ACUTE PV RECONNECTION RATE THAN 50 W APPLICATIONS BUT SIMILAR SAFETY OUTCOMES AND EFFECTIVENESS AT 1 YEAR. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: QDOT-MICRO . OTHER CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: PENTARAY CATHETER. CARTO. NMARQ RADIOFREQUENCY GENERATOR. NON-BIOSENSE WEBSTER CONCOMITANT DEVICES THAT WERE ALSO USED IN THIS STUDY: SENSITHERM, ST JUDE MEDICAL, ST PAUL, MN). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: QTY: (2). TWO CASES OF CARDIAC TAMPONADE OBSERVED WERE UNRELATED TO THE TRANSEPTAL PUNCTURE OR TO THE POWER SETTINGS. RATHER, THEY WERE ATTRIBUTED TO EXCESSIVE CF VALUES (MECHANICAL TRAUMA) OBSERVED AT CERTAIN (B)(6) LOCATIONS DURING THOSE 2 PVI PROCEDURES. THERE IS NO MENTION OF INTERVENTION PROVIDED OR IF THE PATIENT REQUIRED EXTENDED HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53009 UNK_QDOT MICRO CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| L CARTO| NMARQ RADIOFREQUENCY GENERATOR| PENTARAY CATHETER| SENSITHERM, ST JUDE MEDICAL, ST PAUL, MN)