MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number UNK_NAVISTAR THERMOCOOL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 10/07/2020

Event Type  Injury  

Manufacturer Narrative

Manufacture ref no: (b)(4).This complaint is from a literature source.Reinsch n, füting a, buchholz j, ruprecht u, neven k.Influence of ablation index on the incidence of cardiac tamponade complicating pulmonary vein isolation.Herz.2021 sep;46(suppl 2):228-234.English.Doi: 10.1007/s00059-020-04988-y.Epub 2020 oct 7.Pmid: 33026484.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.

Event Description

This complaint is from a literature source.Reinsch n, füting a, buchholz j, ruprecht u, neven k.Influence of ablation index on the incidence of cardiac tamponade complicating pulmonary vein isolation.Herz.2021 sep;46(suppl 2):228-234.English.Doi: 10.1007/s00059-020-04988-y.Epub 2020 oct 7.Pmid: 33026484.Objective/methods/study data: the authors tried to hypothesize the use of ai reduces the incidence of ct.All af procedures between 10/2014 and 06/2019 were included.Three ablation groups were defined: group a, rf ablation with non-contact force (cf) catheter; group b, rf ablation with cf catheter; and group c, rf ablation with cf catheter using ai.All episodes of ct were analyzed.In total, 1222 consecutive af patients underwent pvi.Group a consisted of 100 (8%) procedures, while group b included 432 (35%) procedures and group c 690 (57%) procedures.The overall risk for ct in all patients was 2.1% (26/1222).The risk in group a was 2.9% (3/100), in group b 2.5% (11/432), and in group c 1.7% (12/690), including all 1222 patients in the analysis (p<0.05).Univariate analysis identified no further specific predictors for ct.With the exception of one patient (1/26; 3.8%), who needed surgical treatment, all ct could be successfully drained.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: 3.5-mm thermocool navistar® catheter.Other biosense webster devices that were also used in this study: carto 3.20-pole circular catheter (lasso).Visitag®( biosense webster, inc., (b)(4), usa).Non-biosense webster devices that were also used in this study: cyroballow group: decapolar electrode catheter, two fixed-curve sheaths (8.5 f sl1 fast-cath guiding introducer, st.Jude medical, minneapolis, mn, usa), 3.5- mm mapping and ablation catheter.Adverse event(s) and provided interventions (associated with ablation in the cf group): qty 26- cardiac tamponade- successful and uncomplicated pericardiocentesis performed in all patients.Qty 1- cardiac tamponade- needed surgical treatment.

• Brand Name: NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 15516698
• MDR Text Key: 300904239
• Report Number: 2029046-2022-02354
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NAVISTAR THERMOCOOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2022
• 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: 20-POLE CIRCULAR CATHETER (LASSO); 3.5- MM MAPPING AND ABLATION CATHETER.; DECAPOLAR ELECTRODE CATHETER; TWO FIXED-CURVE SHEATHS 8.5 F SL1 FAST-CATH; UNK_CARTO 3; VISITAG®( BIOSENSE WEBSTER, INC., (B)(4))
• Patient Outcome(s): Required Intervention; Life Threatening