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 Problem Paralysis (1997)

Event Date 05/09/2023

Event Type  Injury  

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).The bwi product analysis lab received the device for evaluation on 02-jun-2023.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 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.Manufacturer's reference number: (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.The patient suffered a diaphragmatic paralysis.Event was a phrenic nerve palsy, temporal loss of phrenic nerve response.It was reported that the ablation with upper limit 25w 5s was performed using thermocool® smart touch® sf bi-directional navigation catheter at the lesion which could identify diaphragmatic twitching in detail.After 5 seconds ablation, phrenic nerve response was lost.Timing was after 5 seconds ablation, the second physician reported that the response was lost.Checked phrenic nerve response at the area which was confirmed to be near the presence of phrenic nerve prior, but the response was lost.After waiting, checked it again and some response was recovered, so the patient was put under observation.Cf monitoring was real time graph, dashboard and vector.Visitag coloring setting was tag index.Visitag additional filter was fot.The physician's comment on the relationship between this event and the product was that there was no causal relationship with biosense webster inc.Products and the issue was non-serious (moderate/minor).There was no abnormality before and while using the product.Additional information was received.The adverse event was discovered during use of biosense webster products.Physician¿s opinion on the cause of this adverse event was that physician said no idea why this happened.Ablation was provided with even 5 seconds and phrenic nerve was stimulated with low stimulation.No intervention was provided.Outcome of the adverse event was fully recovered.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a diaphragmatic paralysis.The device evaluation was completed on 14-jun-2023.The product was returned to biosense webster (bwi) for evaluation.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.Physician¿s opinion on the cause of this adverse event was that physician said no idea why this happened.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17056885
• MDR Text Key: 316479888
• Report Number: 2029046-2023-01215
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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: 07/10/2023

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: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 31025342L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 06/05/2023
• Supplement Dates Manufacturer Received: 06/14/2023
• Supplement Dates FDA Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2023
• 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: UNK_CARTO 3.
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 62 KG