MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT MICRO; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Catalog Number UNK_QDOT MICRO

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Transient Ischemic Attack (2109)

Event Date 12/23/2023

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: popa ma, bahlke f, kottmaier m, foerschner l, bourier f, lengauer s, telishevska m, krafft h, englert f, reents t, lennerz c, caluori g, jaïs p, hessling g, deisenhofer i.Myocardial injury and inflammation following pulsed-field ablation and very high-power short-duration ablation for atrial fibrillation.J cardiovasc electrophysiol.2024 feb;35(2):317-327.Doi: 10.1111/jce.16157.Epub 2023 dec 17.Pmid: 38105426.Objective/methods/study data: introduction: pulmonary vein isolation (pvi) using radiofrequency ablation (rfa) is an established treatment strategy for atrial fibrillation (af).To improve pvi efficacy and safety, high-power short-duration (hpsd) ablation and pulsed-field ablation (pfa) were recently introduced into clinical practice.This study aimed to determine the extent of myocardial injury and systemic inflammation following pfa, hpsd, and standard rfa using established biomarkers.Methods: we included 179 patients with paroxysmal af receiving first-time pvi with different ablation technologies: standard rfa (30-40 w/20-30 s, n = 52), power-controlled hpsd (70 w/5-7 s, n = 60), temperature-controlled hpsd (90 w/4 s, n = 32), and pfa (biphasic, bipolar waveform, n = 35).High-sensitivity cardiac troponin t (hs-ctnt), creatine kinase (ck), ck mb isoform (ck-mb), and white blood cell (wbc) count were determined before and after ablation.Results: baseline characteristics were well-balanced between groups (age 63.1 ± 10.3 years, 61.5% male).Postablation hs-ctnt release was significantly higher with pfa (1469.3 ± 495.0 ng/l), hpsd-70w (1322.3 ± 510.6 ng/l), and hpsd-90w (1441.2 ± 409.9 ng/l) than with standard rfa (1045.9 ± 369.7 ng/l; p <.001).Ck and ck-mb release was increased with pfa by 3.4-fold and 5.8-fold, respectively, as compared to standard rfa (p <.001).Pfa was associated with the lowest elevation in wbc (1.5 ± 1.5 × 109 /l), as compared to standard rfa (3.8 ± 2.5 × 109 /l, p <.001), hpsd-70w (2.7 ± 1.7 × 109 /l, p =.037), and hpsd-90w (3.6 ± 2.5 × 109 /l, p <.001).Conclusion: among the four investigated ablation technologies, pfa was associated with the highest myocardial injury and the lowest inflammatory reaction.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events in the hpsd-90w group: qdot micro catheter.Biosense webster devices that were used in this study in the hpsd-90w group: carto vizigo sheath, carto 3 system, lasso mapping catheter, ngen rf generator non-biosense webster devices that were also used in this study in other groups: swartz braided lamp 45 sheath (abbott), flexbility se catheter, ampere rf generator, ensite precision system (abott), advisor mapping catheter (abbott) adverse event(s) and provided interventions possibly associated with unidentified qdot micro ablation catheter in the hpsd-90w group: qty 1 (transient ischemic attack) (recognized procedural complication) in table 3 and no further information provided regarding intervention.

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: popa ma, bahlke f, kottmaier m, foerschner l, bourier f, lengauer s, telishevska m, krafft h, englert f, reents t, lennerz c, caluori g, jaïs p, hessling g, deisenhofer i.Myocardial injury and inflammation following pulsed-field ablation and very high-power short-duration ablation for atrial fibrillation.J cardiovasc electrophysiol.2024 feb;35(2):317-327.Doi: 10.1111/jce.16157.Epub 2023 dec 17.Pmid: 38105426.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).

• Brand Name: QDOT MICRO
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18914731
• MDR Text Key: 337792078
• Report Number: 2029046-2024-00852
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835016710
• UDI-Public: 10846835016710
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P210027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_QDOT MICRO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; UNK_CARTO VIZIGO SHEATH; UNK_LASSOSTAR CATHETER; UNK_NGEN RF GENERATOR
• Patient Outcome(s): Other