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

Model Number D134805

Device Problems Device Contamination with Body Fluid (2317); Patient Device Interaction Problem (4001)

Patient Problem Stroke/CVA (1770)

Event Date 03/22/2023

Event Type  Injury  

Manufacturer Narrative

E1 initial reporter phone: (b)(6).Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a cerebrovascular accident.It was reported that after the use of the catheters, char was discovered visually on stsf and octaray when the catheters were removed.Timing when complaints occurred was three hours after use of the catheters.At the end of the catheters¿ operation.The physician noticed the event by visual inspection when removing the catheters from the patient¿s body.There were no problems about temperature, impedance value, and irrigation.Ablation time did not exceed 60 seconds (per ablation).Ablation time did not exceed 120 seconds (per ablation).Total ablation time was one hour, 3 minutes, 43 second.It is unknown if the mean cf value exceeded 25g and 40g.Irrigation setting was within the recommended range.The setting of pre rf (radiofrequency) time and post rf time: pre1sec post5sec.Set power was 20-45w.After entering the room, the patch was attached to the patient.The patch no.4 on the chest was not displayed when checking the location screen.Timing when complaints occurred was after entering the room.The issue was not resolved by re-entering study and rebooting the patient interface unit (piu).The issue was improved by replacing the patch unit.When the patch unit was checked, the yellow cable was physically damaged.Version information: v7.2.40.250." pentaray had char on the spine, but it was unknown whether on electrode or not.No error message observed during the procedure.Generator parameters- -power control mode, cut-off temperature: 42, cut-off impedance: 200o.Power: 20-45w.The patient was anticoagulated during the procedure, but act practice was unknown.Smartablate system rf generator jp, m4900202, sn: (b)(6) was used.Smartablate system irrigation pump jp, m4900203, sn: (b)(6) was used.Pictures not available.No neurological symptom occurred since the procedure was completed.Correct catheter settings were selected on the generator.Pump switching was from ¿low¿ to ¿high¿ flow during ablation.The duration of ablation used was not greater than 60 seconds or greater than 120 seconds.Irrigation rate was not used outside of those prescribed.Pre-ablation high setting was pre 1sec.Post 5sec.Heparinized normal saline was used.Carto visitag module was used ; respiration setting: on, stability range: 3mm, stability time: 6s, force over time: 25%, tag size:2.Tag index was used.Char was also adhered to the octaray catheter not only stsf catheter.The octaray sometimes got to close to the stsf catheter during the ablation procedure.Continuous flush with heparinized saline solution was done during the procedure.Cerebral infarct has occurred after the procedure.After the procedure, patient did not awake for a while and cerebral infarct was diagnosed on several findings.On (b)(6) 2023, the patient visited the hospital for a follow-up outpatient visit, the cerebral infarct has improved with no residual consequences.Extended hospitalization: yes, target arrhythmia, atrial fibrillation.Adverse event: cerebral infarct.Physician's comment on the relationship between this event and the product was that there was a relationship between the cerebral infarct and the catheter.The severely was non-serious(moderate/minor).There was no abnormality before using the product.There was an abnormality while using the product.Additional information: the adverse event occurred on (b)(6)2023.It was discovered post use of biosense webster products.Outcome of the adverse event was fully recovered (no residual effects).On (b)(6) 2023, the patient visited the hospital for a follow-up outpatient visit, the cerebral infarction has improved with no residual consequences.Extended hospitalization was required for follow-up observation of the cerebral infarction.Smartablate rf generator , m4900202, sn: (b)(6) was used.Char is not mdr-reportable.Since the event is 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 is to be considered serious.

Manufacturer Narrative

On 21-june-2023, the product investigation was completed as the complaint device was not returned.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30966124l number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• 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: 17021676
• MDR Text Key: 316140513
• Report Number: 2029046-2023-01170
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

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
• Device Lot Number: 30966124L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2023
• Initial Date FDA Received: 05/30/2023
• Supplement Dates Manufacturer Received: 06/21/2023
• Supplement Dates FDA Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/16/2022
• 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 WITH CARTO MERGE; OCTARAY CATHETER; SMARTABLATE GENERATOR; SMARTABLATE PUMP
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Male