MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D134801

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Paralysis (1997)

Event Date 03/11/2024

Event Type  Injury  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced diaphragmic paralysis that required patient is to be monitored.After finishing pulmonary vein isolation (pvi) + cavotricuspid ishmus (cti) and starting on superior vena cava (svc), the event was detected because twitch could not be felt no matter where pacing was put in.After the patient woke up from the anesthesia and was in sinus state, the fluoroscopy showed that only the right side of the patient's diaphragm had significantly decreased movement (not completely inactive, according to the doctor).It was also mentioned by a physician that as far the patient was examined, there was no difference in the height of the chest area from left to right.The patient will be monitored for the time being.The catheter was returned because effects due to right pulmonary vein isolation (rpvi) was suspected.Physicians commented that in this case, the event occurred probably not due to rpvi.They commented that they would understand that the cause might be the ablation if it had been ablated closer to the pv based on the driving and lineation seen on univu and ct.The situation is that they are struggling to figure out why it has happened.No mention of association with the product.Judging from the anatomy confirmed by ct, fam, uniuv, and fluoroscopy and this lineage, it was unlikely that the event would occur.This is the first case of phrenic nerve disorder in radiofrequency (rf) ablation.The patient was alive in the hospital under observation.The cause of the event was not clear.Rpvi was thought to be the only possible cause because only pvi+cti was done.

Manufacturer Narrative

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.E1.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

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced diaphragmic paralysis that required patient is to be monitored.After finishing pulmonary vein isolation (pvi) + cavotricuspid ishmus (cti) and starting on superior vena cava (svc), the event was detected because twitch could not be felt no matter where pacing was put in.After the patient woke up from the anesthesia and was in sinus state, the fluoroscopy showed that only the right side of the patient's diaphragm had significantly decreased movement (not completely inactive, according to the doctor).It was also mentioned by a physician that as far the patient was examined, there was no difference in the height of the chest area from left to right.The patient will be monitored for the time being.Device evaluation details: on 23-apr-2024, the device was returned to biosense webster inc (bwi) for evaluation.The evaluation has been completed.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 non-conformances were identified.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) contains the following warning and precautions: when using the catheter with conventional systems (using fluoroscopy to determine catheter tip location), or with the carto¿ 3 system, careful catheter manipulation must be performed in order to avoid cardiac damage, perforation, or tamponade.Do not use excessive force to advance or withdraw the catheter when resistance is encountered.The firmness of the braided tip dictates that care must be taken to prevent perforation of the heart.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 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 19048158
• MDR Text Key: 339435801
• Report Number: 2029046-2024-01136
• 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
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134801
• Device Lot Number: 31170009L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: No
• 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; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Other
• Patient Sex: Male