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 Problems Laceration(s) of Esophagus (2398); Perforation of Esophagus (2399); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/04/2022

Event Type  Injury  

Event Description

It was reported that a 66-year-old male patient underwent an atrial fibrillation (afib) ablation procedure on (b)(6) 2022 with a thermocool® smart touch® sf bi-directional navigation catheter and an ngen rf generator, world wide configuration, and experienced a thermal lesion and an esophageal perforation which required prolonged hospitalization.This event is regarding clinical: (b)(4).Thermal lesion was reported on (b)(6) 2022.Per the study investigator, the adverse event is severe and serious and the patient did not die.The event is both serious and procedure related, and not expected/anticipated in the opinion of the investigator.There was a serious deterioration in the health of the subject and it was not considered a life-threatening illness or injury.No permanent impairment of a body structure or a body function including chronic diseases.In-patient or prolongation hospitalization was required from (b)(6) 2022 to (b)(6) 2022.No medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function was required.Relationship to study device, thermocool® smart touch® sf bi-directional navigation catheter, not related.Relationship to study device, ngen rf generator, world wide configuration, possible.Per the study investigator, the relationship to study procedure is possible.The event is related to the index procedure.There was no intervention/ treatment.Medication was given.No cardioversion was performed.It was not a re-ablation procedure.No surgery was performed.Other intervention was parenteral nutrition and esophageal clipping.Additional information was received on 8-oct-2022 for thermal lesion.Relationship to study procedure: causal relationship.End date: (b)(6) 2022.Outcome: not recovered/not resolved.Discharge date: (b)(6) 2022.Esophageal perforation was reported on 18-oct-2022.The event start date was (b)(6) 2022.Event type: worsening of a pre-existing condition.Per the study investigator the adverse event is severe and serious, and the patient did not die.There was a serious deterioration in the health of the subject and it was considered a life-threatening illness or injury.No permanent impairment of a body structure or a body function including chronic diseases.In-patient or prolongation hospitalization was required from (b)(6) 2022 to (b)(6) 2022.Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function was provided.Per the study investigator the relationship to study procedure: causal.The adverse event is expected/anticipated.There was no intervention/ treatment.Medication was given.No cardioversion was performed.It was not a re-ablation procedure.No surgery was performed.Other intervention was performed; other intervention performed is parenteral nutrition and esophageal clipping.Per study investigator relationship to study devices; carto; pentaray; and vizigo sheath; are not related.

Manufacturer Narrative

The initial reporter phone: (b)(6).(b)(4).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.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter) (2) mfr # 2029046-2022-02730 for product code d138401 (ngen rf generator, world wide configuration).

Manufacturer Narrative

On 03-nov-2022, additional information was received.It was reported that for thermal lesion (ae1), the outcome value has been updated to ¿recovered/ resolved with sequelae¿.For esophageal perforation (ae2) - relationship to study device index: generator: ngen: d138401: possible.Relationship to study device thermocool smarttouch sf: d134805 is possible.The adverse event is expected/anticipated.The outcome value has been changed to ¿recovered/ resolved with sequelae¿.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2022-02729 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter) (2) mfr # 2029046-2022-02730 for product code d138401 (ngen rf generator, world wide configuration).

Manufacturer Narrative

Additional information was received on 10-feb-2023.It was reported that the second adverse event was inactivated.On 14-feb-2023, it was reported that the adverse event term value "esophageal thermal lesion" has been changed to "esophageal perforation".Therefore, there is only one adverse event which is esophageal perforation.As such, the h 6.Health effect - clinical code has been updated and the code of ¿laceration(s) of esophagus (e1018)¿ has been removed.Additional information received was received on 15-feb-2023 and the physician contact information was provided.Therefore, section e for initial reporter has been updated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2022-02729 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter) (2) mfr # 2029046-2022-02730 for product code d138401 (ngen rf generator, world wide configuration).

Manufacturer Narrative

Additional information was received on 13-dec-2022.It was reported that the end date has been updated to 17-oct-2022 regarding esophageal perforation.On 15-dec-2022, it was reported that the adverse event term value "thermal lesion" has been changed to "esophageal thermal lesion, therefore, the h 6.Health effect - clinical code has been updated from ¿injury¿ to ¿laceration(s) of esophagus (e1018)¿.Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number 30857240l, 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.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2022-02729 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter) (2) mfr # 2029046-2022-02730 for product code d138401 (ngen rf generator, world wide configuration).

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) on 16-jan-2023, it was noted that the correct product return status is discarded, instead of what was initially reported as not available for return under 3500a follow up report mwr-15122022-0001317515.Therefore, the ¿h6.Type of investigation¿ field has been updated on this report.

Manufacturer Narrative

Additional information was received on 25-jan-2023.It was reported that the previously reported discharge date value of "(b)(6)2022" has been changed to "(b)(6)2022".If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2022-02729 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter) (2) mfr # 2029046-2022-02730 for product code d138401 (ngen rf generator, world wide configuration).

• 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: 15734764
• MDR Text Key: 303078096
• Report Number: 2029046-2022-02729
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• 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: 30857240L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2022
• 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: NGEN RF GENERATOR; UNK_CARTO 3; UNK_CARTO VIZIGO SHEATH; UNK_PENTARAY
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male