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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Stroke/CVA (1770)

Event Date 04/07/2023

Event Type  Injury  

Event Description

It was reported a patient underwent a left flutter post ablation of atrial fibrillation (afib) cardiac ablation procedure (5th procedure) which included the use of a thermocool® smart touch® sf bi-directional navigation catheter.Patient experienced cerebrovascular accident.Initially it was reported after connecting the catheter to the ngen generator, it was detected but they had the error 273, 182 and 279 intermittently.After turning everything off and on again in order, the problem was not resolved.They changed the cable without solving the problem.To continue the procedure, they used a new catheter.Initially, it was reported that there was a 20 minute surgical delay.The surgery delay was due to this reported event.Surgery was successfully completed.There was no patient consequence reported.Additional information was received on 11-apr-2023.The delay was 1 hour instead of 20 minutes.Reporter was made aware that patient suffered a stroke and had aphasia and facial paralysis.Additional information was received on 17-apr-2023.Physician¿s opinion on the cause of this adverse event was that they had during the procedure a problem of visualization / connection of the thermocool® smart touch® sf bi-directional navigation catheter connected to the ngen generator newly installed in the center.After many attempts to solve the problem of the unknown ngen generator (reignite, change the cables), they made the decision to first change the thermocool® smart touch® sf bi-directional navigation catheter and then to change the generator (use of a smartablate generator).Solving the problem took almost an hour.The doctor therefore considers that this loss of time has increased the risk of stroke for the patient.The thermocool® smart touch® sf bi-directional navigation catheter remained in the patient's heart for a period of time and was then removed.The patient was in arrhythmia and the mapping gave the diagnosis a flutter of the roof in the left atrium.The outcome of the adverse event was unchanged: the patient had a stroke.The patient initially had physical and cognitive issue but his condition improved and he seemed to have recovered these abilities in certain aspects and remains hospitalized.Patient required extended hospitalization because of the adverse events due to the stroke.Patient in the room at the time of the delay.In the physician¿s opinion, the delay did contribute to the adverse event to the patient.Solving the problem took almost an hour.The doctor therefore considers that this loss of time has increased the risk of stroke for the patient.Intervention required due to the delay is management of the stroke.Additional information was received (b)(6) 2023.During the procedure, several solutions were attempted to fix the issue.At first, the cable and the thermocool® smart touch® sf bi-directional navigation catheter were changed by using the ngen.The issue was not solved in this way, a smartablate generator was used to complete the procedure.No request regarding the ngen for servicing or investigation.The ngen was used after without any incident during the next procedures performed the following weeks.This event was originally considered non-reportable, however, bwi became aware of the cerebrovascular accident, surgery prolonged of an hour and prolonged hospitalization on (b)(6) 2023 and have reassessed the event as reportable under the thermocool® smart touch® sf bi-directional navigation catheter with the reportable awareness date of (b)(6) 2023.Since the event was life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it was to be considered serious and mdr-reportable.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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 reference number: (b)(4).

Manufacturer Narrative

Per additional information on 31-jul-2023, it was identified that this report contains duplicative information from the event reported in manufacturer report number 2029046-2023-01507 (unknown smart touch bidirectional sf) and 2029046-2023-01506 (ngen rf generator).Due to the information available at the time of the initial report and follow-up reporting under this complaint file, there was no indication that the generator could have contributed to the event; therefore, this event was previously assessed as mdr reportable only for the catheter.The additional information under manufacturer report number 2029046-2023-01506 makes this event reportable for both devices.The details for the thermocool® smart touch® sf bi-directional navigation catheter shall be found on this current complaint and for the updated information for the ngen rf generator shall be found in manufacturer report number 2029046-2023-01506.The most applicable event summary/event narrative is as follows: it was reported that a patient underwent an atrial fibrillation/ta (tricuspid annulus) ablation procedure (5th procedure) with a thermocool® smart touch® sf bi-directional navigation catheter and a ngen rf generator.Patient experienced cerebrovascular accident.Initially, it was reported after connecting the catheter to the ngen rf generator, it was detected that they had the error 273, 182 and 279 intermittently.They had a problem with the visualization of the catheter, which was neither visualized or recognized by the carto system even though it was connected to the dongle linked to the patient interface unit (piu).After turning everything off and on again in order, the problem was not resolved.In an attempt to resolve the problem, the medical team connected the catheter directly to the patient interface unit (piu) but this did not solve the problem.The medical team also changed the catheter cable and the catheter itself, but the issue was not resolved.As solution, they switched to the smartablate generator.The delay was 1 hour.The procedure was successfully completed.No patient consequences were reported during the procedure, but in the days following the procedure, the patient suffered a stroke.The procedure was on 7-apr-2023.The stroke occurred at some point between 7-apr-2023 and 11-apr-2023.It was reported that the patient has partially recovered.As a result of the stroke, the patient had aphasia and facial paralysis.Physician¿s opinion on the cause of this adverse event was bwi product malfunction linked to the loss of time due to the malfunction of the ngen rf generator.During the procedure, a problem of visualization / connection of the thermocool® smart touch® sf bi-directional navigation catheter connected to the ngen rf generator newly installed in the center.After many attempts to solve the problem of the ngen rf generator (reignite, change the cables), they made the decision to first change the thermocool® smart touch® sf bi-directional navigation catheter and then to change the generator (use of a smartablate generator).Solving the problem took almost an hour.The physician; therefore, considers that this loss of time has increased the risk of stroke for the patient.The thermocool® smart touch® sf bi-directional navigation catheter remained in the patient's heart for a period of time and was then removed.The patient was in arrhythmia and the mapping gave the diagnosis a flutter of the roof in the left atrium.Outcome of the adverse event is improved' however, the medical team did not have detailed information on the patient's condition at the time.The patient initially had physical and cognitive issue but his condition improved and he seemed to have recovered these abilities in certain aspects and remains hospitalized.Patient required extended hospitalization because of the adverse events due to the stroke.The patient was in the room at the time of the delay.The patient's condition was stable and improving in the days and weeks following the stroke.All force visualization features were used.Color options used prospectively was fti 25%; average; force minimum 3 g; time minimum 3 s; other maximun distance change 4 mm; ai 350 400.No evidence of char, blood, or thrombus/clot during the procedure.Correct catheter settings were selected on the generator.Pump switching was from "low" to "high" flow during ablation.In addition, updated the d10.Concomitant medical products and therapy dates field to include ngen pump, eu configuration and carto 3 system.Replaced unk_smartablate generator to smartablate generator kit-ww.Biosense webster has two reports for this adverse event: (1) manufacturer report number 2029046-2023-00957 /manufacturer¿s reference number (b)(4) for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter).(2) manufacturer report number 2029046-2023-01506 / manufacturer¿s reference number (b)(4) for product code d138401 (ngen rf generator).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 17-may-2023.The device evaluation was completed on 25-may-2023.It was reported a patient underwent a left flutter post ablation of atrial fibrillation (afib) cardiac ablation procedure (5th procedure) which included the use of a thermocool® smart touch® sf bi-directional navigation catheter.Patient experienced cerebrovascular accident.The product was returned to biosense webster (bwi) for evaluation.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no temperature values were observed during the analysis due to an open circuit in the tip area; however, this failure observed is not related to the adverse event.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The root cause of the adverse event remains unknown.The physician¿s opinion on the cause of this adverse event is that during the procedure there was a problem of visualization / connection of the stsf catheter connected to the ngen generator newly installed in the center.In addition, no device malfunction was reported, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: -investigation findings: no device problem found (c19)/ investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿adverse event¿.-investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: electrical lead/wire (g02015) were selected as related to the biosense webster inc.Analysis finding of the ¿tc/thr - wires broken¿ issue.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) during an internal review on 29-aug-2023, noted a correction to the 3500a follow-up #2.Initially included in h10.Additional manufacturer narrative added, ¿physician¿s opinion on the cause of this adverse event was bwi product malfunction linked to the loss of time due to the malfunction of the ngen rf generator¿.It should have stated, ¿physician¿s opinion on the cause of this adverse event was bwi product malfunction linked to the loss of time due to the malfunction of the ngen rf generator.Change of the ngen rf generator for the smartablate generator; procedure related as ablation of af (atrial fibrillation) / ta (tricuspid annulus) which was the patient's 5th ablation procedure.".

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16907737
• MDR Text Key: 314972281
• Report Number: 2029046-2023-00957
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/12/2023

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
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 05/17/2023; 07/31/2023; 08/29/2023
• Supplement Dates FDA Received: 06/05/2023; 08/30/2023; 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2023
• 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; NGEN PUMP, EU CONFIGURATION; SMARTABLATE GENERATOR KIT-WW; UNKNOWN BRAND CABLE; UNKNOWN BRAND CABLE; UNKNOWN BRAND CATHETER; UNK_NGEN RF GENERATOR; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Hospitalization; Life Threatening