MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SF UNI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_THERMOCOOL SF NON NAV

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Paralysis (1997)

Event Date 05/30/2022

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature citation has been reviewed: sousa pa, barra s, adão l, primo j, khoueiry z, puga l, lebreiro a, fonseca p, lagrange p, gonçalves l; study group members.Assessment of the need of a waiting period after pulmonary vein isolation with the ablation index software.J cardiovasc electrophysiol.2022 may 30.Doi: 10.1111/jce.15568.Epub ahead of print.Pmid: 35637604.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.The following literature citation has been reviewed: sousa pa, barra s, adão l, primo j, khoueiry z, puga l, lebreiro a, fonseca p, lagrange p, gonçalves l; study group members.Assessment of the need of a waiting period after pulmonary vein isolation with the ablation index software.J cardiovasc electrophysiol.2022 may 30.Doi: 10.1111/jce.15568.Epub ahead of print.Pmid: 35637604.Objective/methods/study data: authors aim to evaluate whether a waiting period is still necessary after pvi guided by the ablation index (ai).Prospective, multicenter, randomized study of consecutive patients referred for paroxysmal af ablation from may 2019 to february 2020 in four tertiary hospitals.The article reports a control group a and study group b.The same devices were utilized in both groups.During the enrollment period, 167 patients (56% males, mean age of 57 ± 14 years) fulfilled the study inclusion criteria ¿ 84 patients (308 pv) in the waiting period group (group a) and 83 patients (314 pv) in the group without a waiting period (group b).Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch sf/rf.Other biosense webster devices that were also used in this study: carto visitag module, lasso nav eco mapping catheter.Non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions: qty 1 phrenic nerve palsy - patient had complete recovery during the first 6 months of follow up - the article does not provide any further information on interventions.

• Brand Name: THERMOCOOL® SF UNI-DIRECTIONAL CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15317585
• MDR Text Key: 298873231
• Report Number: 2029046-2022-02030
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_THERMOCOOL SF NON NAV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2022
• Initial Date FDA Received: 08/30/2022
• 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 VISITAG MODULE; LASSO NAV ECO MAPPING CATHETER
• Patient Outcome(s): Life Threatening