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 Unspecified Tissue Injury (4559)

Event Date 01/25/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered vagus nerve injury requiring prolonged hospitalization.It was reported that the patient's vagus nerve which runs along the esophagus was damaged by heat.No information about if any intervention was performed was provided.The adverse event was discovered post use of biosense webster products.According to the physician in charge, since the procedure itself was performed as usual, the event was attributable to the patient¿s anatomy (patient condition) and not attributable to the product.The doctor in charge thought that there was a problem with the dissection, and it is not due to the product.The patient's hospitalization was prolonged due to the adverse event.Patient was ultimately discharged with no particular problem at present.The patient¿ outcome was reported as fully recovered.The generator parameters were set to power control mode.There were no error messages observed on biosense webster equipment during the procedure.There was no significant patient medical history or laboratory values.

Manufacturer Narrative

Device investigation details: 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 30648162l number, and no internal action related to the complaint was found during the review.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

Device investigation details: 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 30648162l number, and no internal action related to the complaint was found during the review.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered vagus nerve injury requiring prolonged hospitalization.It was reported that the patient's vagus nerve which runs along the esophagus was damaged by heat.No information about if any intervention was performed was provided.The adverse event was discovered post use of biosense webster products.According to the physician in charge, since the procedure itself was performed as usual, the event was attributable to the patient¿s anatomy (patient condition) and not attributable to the product.The doctor in charge thought that there was a problem with the dissection, and it is not due to the product.The patient's hospitalization was prolonged due to the adverse event.Patient was ultimately discharged with no particular problem at present.The patient¿ outcome was reported as fully recovered.The generator parameters were set to power control mode.There were no error messages observed on biosense webster equipment during the procedure.There was no significant patient medical history or laboratory values.

Manufacturer Narrative

On (b)(6) 2022, biosense webster inc received additional information about the patient and event.It was reported the patient was a 72 year-old female, weighing 63 kgs.It was reported that during ablation, the temperature of the esophageal sensor was monitored to ensure that it did not reach 40.The esophageal injury was confirmed by x-ray.The patient fasted for 2 days as part of intervention.Correct catheter settings were selected on the generator, and the pump was switching from ¿low/high¿ flow during ablation.The generator did not malfunction and does not require service.The carto® 3 indicate to re-zero the catheter.Force visualization issues used included dashboard and vector.Visitag parameters for stability were set to, range:2mm time:3 sec force over time (fot):25 and tag size:3 mm and accuresp filter.Color options included ablation index.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13596497
• MDR Text Key: 286130374
• Report Number: 2029046-2022-00376
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2022
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30648162L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2021
• 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; SMARTABLATE GEN. KIT (JAPAN); UNKNOWN PUMP
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 63 KG