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

Model Number D134801

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Laceration(s) of Esophagus (2398)

Event Date 09/21/2022

Event Type  Injury  

Event Description

It was reported that an 78-year-old female patient (146 cm, 43 kg).Underwent a pulmonary vein isolation (pvi) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered an esophageal ulcer.A procedure was for pvi.The physician conducted ablation during a pvi procedure without noticing a temperature increase due to a shift in the position of the esophageal temperature sensor at the time of ablation in the posterior wall.As a result of the test on the next day, no esophageal perforation was found, but an ulcer developed.According to the gastroenterologist, there is a tendency toward improving of the patient's state.Esophageal endoscopy is scheduled to be performed again on (b)(6) 2022.The physician's opinions on the relationship between the event and the product is that there is no relationship with the product.No abnormalities were observed prior to use or during use of the product.The physician¿s opinion on the cause of this adverse event is that it was due to the procedure.The physician commented that they did not notice the temperature increase during the ablation of the posterior wall because the position of the esophageal temperature sensor catheter was deviated.The esophageal temperature sensor catheter was not bw product.Servicing for the generator was not required.No error messages were observed on biosense webster equipment during the procedure.Esophageal temperature sensor catheter was used to prevent esophageal injury.Esophageal injury was confirmed with esophagoscopy on the next day.The carto® 3 system did not indicate to re-zero the catheter.Real time graph; dashboard; vector; visitag force visualization features were used.Fot additional filter was used with the visitag.Tag index color option was used prospectively.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 and mdr-reportable.

Manufacturer Narrative

Initial reporter phone: (b)(6).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.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

On 17-oct-2022, bwi received additional information regarding the event.Physician¿s opinion on the cause of this adverse event was procedure.The physician commented that they did not notice the temperature increase during the ablation of the posterior wall because the position of the esophageal temperature sensor catheter was deviated.The esophageal temperature sensor catheter was not bw product.No intervention was required.Only a wait-and-see approach was taken.The outcome of the adverse event was fully recovered, and the patient was discharged from the hospital on (b)(6)2022.Extended hospitalization was required for observation for esophageal ulceration.Esophagoscopy was performed again on (b)(6)2022 and there was no worsening trend of esophageal ulcer, and healing was confirmed.No relevant medial history.Generators make and model is smart ablate generator, catalog no:m4900202, with serial number: (b)(6).The servicing for the generator was not required.Generator parameters include power control mode, power: 35w, temperature cut-off value: 40, impedance cut- off value: max250o, min50o.The noted temperature, impedance, and power at the time of the perforation was temperature:25~28, impedance value:143~110o, power:4~36w, ablation time:14.70sec.No error message observed during the procedure.Modalities used to prevent esophageal injury was a esophageal temperature sensor catheter.Esophageal injury was confirmed with esophagoscopy on the next day of the procedure.Correct catheter settings were selected on the generator.Pump switching was from ¿low¿ to ¿high¿ flow during ablation.The carto® 3 system did not indicate to re-zero the catheter.The carto file was shared in the email provided.The force visualization features used were real time graph; dashboard; vector; and a visitag.The parameters for stability for the visitag module used was max distance change:1.5, min time:3sec, force over time:25%, min force:3g.Additional filter used with the visitag was fot.Color options used was a tag index.The lot number of the thmcl smtch sf bid, tc, d-d catheter (d134801) that was used was 30822376l" in section b2, "prolonged hospitalization" is now selected.In section h6, "hospitalization or prolonged hospitalization" (f08) was selected as a health effect - impact code due to the prolonged hospitalization.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

On (b)(6)2022, 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 30822376l 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: pc-(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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15613175
• MDR Text Key: 301822826
• Report Number: 2029046-2022-02544
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2022

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 Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30822376L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/16/2022
• Supplement Dates Manufacturer Received: 10/17/2022; 11/27/2022
• Supplement Dates FDA Received: 11/07/2022; 11/27/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/22/2022
• 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.; CARTO VISITAG MODULE.; UNSPECIFIED GENERATOR.
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 43 KG