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 05/10/2022

Event Type  Injury  

Manufacturer Narrative

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.A device history record evaluation was performed for the finished device 30706925l 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).

Event Description

It was reported that a female patient underwent an unknown ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered esophageal ulcer requiring prolonged hospitalization.After the procedure, esophageal ulcer was confirmed.Ablation was performed with ablation index (ai) of 400, cf of 10 ~ 15 g, ablation time of 10 to 14 seconds, and 30 ~ 35 w.During the procedure, there was no abnormally, and the procedure was completed.The patient is currently under treatment of fasting and the patient is recovering.The physician's opinions on the relationship between the event and the product: there was no abnormality in the product.There was no data of the abnormal value about ai and cf, and the cause was unknown.There was no notable past medical history.There was no bw product malfunction.The physician commented that the cause was unknown because there was no data on abnormal values of ai and cf.The patient is currently under treatment of fasting and the patient is recovering.The patient outcome of the adverse event was improved.The patient required extended hospitalization because of the adverse event and was treated with fasting.The generator used in the case was smartablate.No error messages were observed on biosense webster equipment during the procedure.Force visualization features used were dashboard, vector and visitag with fot and tag index.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

On 28-jun-2022, bwi received additional information regarding the event.The bwi sheath was not used.It was a sheath (swartz sl0).The physician¿s opinion on the cause of this adverse event was not related with the bw product malfunction.There was no bw product malfunction.The cause of the adverse event was unknown because there were no issues with ai value and contact force.The team monitored esophageal temperature.On 30-jun-2022, bwi received further information.The generator parameter setup: 30-35 w, temperature control mode was used, temperature alert: 40, cutoff temperature: 43, noted temperature when the adverse event occurred: 26, noted impedance value when the adverse event occurred: 140 ~ 130o, noted power when the adverse event occurred: 35 w.Modality for prevention of esophageal injury: monitoring esophageal temperature with an esophageal catheter.The correct catheter setting was selected on the generator.The pump irrigation flow rate setting was normally controlled by the generator without any issues.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14615240
• MDR Text Key: 293440015
• Report Number: 2029046-2022-01217
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2023
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30706925L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/10/2022
• 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.; SMARTABLATE GENERATOR.
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Sex: Female