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 Paralysis (1997)

Event Date 07/13/2022

Event Type  Injury  

Event Description

It was reported that a female patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered diaphragmatic nerve palsy.During right pulmonary vein (rpv) anterior wall ablated, diaphragm elevation was confirmed.Transient phrenic nerve palsy was suspected because slight movement was observed with deep breathing.The procedure was continued and completed without any problem.The place where rpv entered inside the pv was ablated, and the risk was high.Ai 400, 45 w ablation.Temperature 26.Impedance around 120.There were no problems with vital signs, and the patient¿s condition was resolving.The physician's opinions on the relationship between the event and the product was that there was no problem with the product.Because the frequency of breathing was low from the beginning and the movement was small, it was difficult to confirm the decrease in the movement of breathing during the ablation.Additional information was received on the event.This adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event is due to patient condition.The patient outcome of the adverse event is fully recovered.The patient did not require extended hospitalization because of the adverse event.It was unclear if there was any additional medication administration.The patient recovered within a few days after the procedure.

Manufacturer Narrative

Initial reporter phone: (b)(6).The device has been reported as discarded, 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 30763053l and no internal actions 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.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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Additional progress was received on 04-aug-2022.The condition tends to improve.It is unclear whether he received additional medication or he recovered within a few days after surgery.No extension of 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).During an internal review on 07-aug-2022 noted a correction to the 3500a initial as in error omitted the physician information.Therefore, processed section e.Initial reporter.

• 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 ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15180852
• MDR Text Key: 297412017
• Report Number: 2029046-2022-01808
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/31/2022

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 Expiration Date: 03/29/2023
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30764086L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2022
• Initial Date FDA Received: 08/08/2022
• Supplement Dates Manufacturer Received: 08/04/2022
• Supplement Dates FDA Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• 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: SOUNDSTAR ECO SMS 8F CATHETER; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Other
• Patient Sex: Female