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

Model Number D134701

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pericardial Effusion (3271)

Event Date 03/09/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a premature ventricular contraction ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a pericardial effusion requiring prolonged hospitalization.It was reported that steam pop occurred during ablation of the right ventricular outflow tract (rvot).Timing when complaints occurred was during rvot ablation.Pericardial effusion was confirmed by surface echography.When the physician checked again 30 minutes and 1 hour later, pericardial fluid did not increase.Therefore, the patient was followed up without performing drainage, etc.Additional information was received on (b)(6) 2023.The adverse event was discovered during use of biosense webster products.No medical intervention required.The steam pop issue occurred during the ablation phase.Thermocool smarttouch sf catheter was used.No error observed.Additional information was received on (b)(6) 2023.Extended hospitalization was required.After that, the patient¿s condition was recovered, and the patient was discharged from the hospital.The physician's opinions on the relationship between the adverse event and the product was that the causal relationship between the product and the adverse event was unknown.Relevant medical history is none.Relevant tests/laboratory data was none.Additional information was received on (b)(6) 2023.No servicing was required to the smartablate generator.Additional information was received on (b)(6) 2023.No medical intervention required.Event occurred during ablation phase.After steam pop occurred, blood pressure was stable.The patient was checked by echography again 30 minutes later and 1 hour later, but pericardial effusion did not increase, so the patient was followed up at rest.Hospitalization was extended, but the patient got recovered and was discharged from the hospital.The patient required extended hospitalization for follow-up.Generator parameters were power control mode.Cut-off: setting as default and power 25~30w.The length (minutes and seconds) of the ablation cycle when the pop was observed at the same tip position "ablation was once at applicable part.Ablation time was about 30 seconds." no errors were observed on any biosense webster systems.This adverse event was originally considered non-reportable as assessed as patient event non serious, however, bwi became aware of additional information that confirmed that the patient required extended hospitalization and have reassessed the event as reportable.The reportable awareness date is (b)(6) 2023.

Manufacturer Narrative

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).

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 24-apr-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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent a premature ventricular contraction ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a pericardial effusion requiring prolonged hospitalization.The device evaluation was completed on 25-may-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.The physician's opinions on the relationship between the adverse event and the product was that the causal relationship between the product and the adverse event was unknown.In addition, no device malfunction was reported, 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) 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 UNI-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: 16704464
• MDR Text Key: 312935730
• Report Number: 2029046-2023-00754
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: 10846835009774
• 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,Followup
• Report Date: 06/21/2023

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: D134701
• Device Catalogue Number: D134701
• Device Lot Number: 30850586L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2023
• Initial Date FDA Received: 04/07/2023
• Supplement Dates Manufacturer Received: 04/24/2023; 05/25/2023
• Supplement Dates FDA Received: 05/17/2023; 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2022
• 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: 7FR DECAN,11P,D,2.4MMLE,282MM,; SMARTABLATE GEN. KIT (JAPAN)
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 88 KG