MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	D132701
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pericarditis (4448); Insufficient Information (4580)
Date of Event	01/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This complaint is from a literature source.The following literature cite has been reviewed: van der heijden caj, weberndörfer v, vroomen m, luermans jg, chaldoupi sm, bidar e, vernooy k, maessen jg, pison l, van kuijk smj, la meir m, crijns hjgm, maesen b.Hybrid ablation versus repeated catheter ablation in persistent atrial fibrillation: a randomized controlled trial.Jacc clin electrophysiol.2023 jan 10:s2405-500x(22)01143-4.Doi: 10.1016/j.Jacep.2022.12.011.Epub ahead of print.Pmid: 36752455.Objective/methods/study data:the purpose of this study was to compare the effectiveness and safety of ha with ca in a prospective, superiority, unblinded, randomized controlled trial.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: hybrid procedure (ha): 3.5-mm tip ablation catheter (thermocool smarttouch, biosense webster) other biosense webster devices that were also used in this study: catheter ablation (ca): an irrigated tip contact force mapping catheter (thermocool smarttouch, biosense webster), automated lesion tagging (visitag, biosense webster) non-biosense webster devices that were also used in this study: bipolar radiofrequency (rf)-clamp (synergy system, atricure), unidirectional bipolar rf pen (coolrail, atricure), epicardial clipping device (atriclip pro or atriclip pro 2, atricure) or an laa closure device (lariat, sentreheart), adverse event(s) and provided interventions: in the ha, 1 patient had a pericarditis requiring pericardiocentesis.In the ha group - 1 patient underwent a staged epi/endocardial procedure due to malfunction of the equipment for the endocardial ablation.
Additional Manufacturer Narrative
This complaint is from a literature source.The following literature cite has been reviewed: van der heijden caj, weberndörfer v, vroomen m, luermans jg, chaldoupi sm, bidar e, vernooy k, maessen jg, pison l, van kuijk smj, la meir m, crijns hjgm, maesen b.Hybrid ablation versus repeated catheter ablation in persistent atrial fibrillation: a randomized controlled trial.Jacc clin electrophysiol.2023 jan 10:s2405-500x(22)01143-4.Doi: 10.1016/j.Jacep.2022.12.011.Epub ahead of print.Pmid: 36752455.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: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Common Device Name: 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17168732
• Report Number: 2029046-2023-01339
• Device Sequence Number: 7201071
• Product Code: LPB
• UDI-Device Identifier: 10846835009163
• UDI-Public: 10846835009163
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P030031/S053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2023

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
• Operator of Device: Health Professional
• Device Model Number: D132701
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (THERMOCOOL SMARTTOUCH, BIOSENSE WEBSTER.; BIPOLAR RF-CLAMP (SYNERGY SYSTEM, ATRICURE).; EPICARDIAL DEV (ATRICLIP PRO OR PRO 2, ATRICURE).; LAA CLOSURE DEVICE (LARIAT, SENTREHEART).; UNIDIRECTIONALBIPOLAR RF PEN (COOLRAIL, ATRICURE).; VISITAG, BIOSENSE WEBSTER.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown