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

Catalog Number UNK_QDOT MICRO

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Laceration(s) of Esophagus (2398); Pericarditis (4448)

Event Date 06/23/2022

Event Type  Injury  

Manufacturer Narrative

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: o'neill l, el haddad m, berte b, kobza r, hilfiker g, scherr d, manninger m, wijnmaalen ap, trines sa, wielandts jy, gillis k, lycke m, de becker b, tavernier r, le polain de waroux jb, knecht s, duytschaever m.Very high-power ablation for contiguous pulmonary vein isolation: results from the randomized power plus trial.Jacc clin electrophysiol.2023 apr;9(4):511-522.Doi: 10.1016/j.Jacep.2022.10.039.Epub 2023 jan 18.Pmid: 36752467.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).

Event Description

This complaint is from a literature source: o'neill l, el haddad m, berte b, kobza r, hilfiker g, scherr d, manninger m, wijnmaalen ap, trines sa, wielandts jy, gillis k, lycke m, de becker b, tavernier r, le polain de waroux jb, knecht s, duytschaever m.Very high-power ablation for contiguous pulmonary vein isolation: results from the randomized power plus trial.Jacc clin electrophysiol.2023 apr;9(4):511-522.Doi: 10.1016/j.Jacep.2022.10.039.Epub 2023 jan 18.Pmid: 36752467.Objective/methods/study data: in this multicenter, randomized controlled trial, the authors compared procedural efficiency, efficacy, and safety of pvi using 90-w/4-second ablation to 35/50-w ablation.Patients with paroxysmal or persistent atrial fibrillation undergoing first-time pvi were randomized to pulmonary vein encirclement with contiguous applications using very high-power, short-duration applications (90 w over 4 seconds) or 35/50-w applications (titrated up to ablation index >550 anteriorly and >400 posteriorly).Prospective endpoints were procedural efficiency (procedure time and first-pass isolation), safety (including esophageal endoscopic evaluation), and 6-month effectiveness using repetitive holter monitoring.A total of 180 patients were randomized, 90 to the 90-w group (mean age: 64.2 8.9 years) and 90 to the 35/50-w group (mean age: 62.3 10.8 years).Procedural time was shorter in the 90-w group vs the 35/50-w group.(70 [iqr: 60-80] minutes vs 75 [iqr: 65-88.3] minutes; p ¼ 0.009).A nonsignificant trend towards lower rates of first-pass isolation was seen in the 90-w group (83.9% vs 90%; p ¼ 0.0852).No major complications were observed in both groups with esophageal injury occurring in 1 patient per group.At 6 months, 17% of patients in the 90-w group vs 15% in the 35/50-w group experienced recurrent arrhythmia (p ¼ 0.681 lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: qdot micro catheter.Other biosense webster concomitant devices that were also used in this study: carto-3, 3-dimensional mapping system and nmarq rf generator (biosense webster, diamondbar, california), lasso catheter (biosense webster).Non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions: qty 1 one esophageal ulcer was noted in the conventional group, treated with high-dose proton pump inhibitor with regression observed at 10 days qty 1- one small, superficial esophageal erosion was observed in the 90-w group that had fully resolved 1 week later- coded as esophageal ulcer qty 1- one patient in the 35/50-w group developed acute dressler syndrome which was successfully managed with colchicine and corticosteroids- coded as pericarditis.

• Brand Name: UNK_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: 17620848
• MDR Text Key: 321927181
• Report Number: 2029046-2023-01890
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P210027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• 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: 05/25/2023
• 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: NMARQ RF GENERATOR (BIOSENSE WEBSTER); UNK_CARTO 3; UNK_LASSO
• Patient Outcome(s): Life Threatening; Required Intervention