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 Problems Bradycardia (1751); Pericardial Effusion (3271)

Event Date 09/30/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone:(b)(6).An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device number lot 30787584l and no internal action related to the complaint was found during the review.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).

Event Description

It was reported that a 73-year-old female underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered pericardial effusion and bradycardia which required surgical intervention.It was reported that when pulmonary vein isolation (pvi) was performed in an afib procedure, decreased blood pressure was confirmed.Pericardial effusion (pe) was confirmed by intracardiac echo.Timing when compliant occurred was after completion of right pulmonary vein (rpv) isolation and during conducting ablation of left pulmonary vein (lpv) which was approximately 1 hour after the start of the procedure.The patient was followed up for about 30 minutes, the amount of pericardial fluid remained unchanged, therefore, drainage was not performed.Blood pressure decreased and bradycardia occurred, temporary pacemaker was implanted, and the patient left the room.The physician's opinions on the relationship between the event and the product was that the cause is unknown.There were no abnormalities observed prior to use and during use of the product.Ablation was performed prior to noting the pe.No error message was observed on biosense webster equipment during the procedure.The force visualization features used were dashboard; vector; and visitag.The additional filter used with the visitag was fot.The color options used was tag index.Parameters for stability used was surpoint.The patient fully recovered and was discharged from the hospital.Patient did not require extended hospitalization because of the adverse event.No relevant test.Generator was a smartablate generator, the serial number was unknown.Fukuda rf needle was used for the transseptal puncture performed.There was no evidence of steam pop.The flow setting for the irrigated catheter used in the event was pre 1sec, post 1 sec.Correct catheter settings were selected on the generator.

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation.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

The device evaluation was completed on 01-feb-2023.It was reported that a 73-year-old female underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered pericardial effusion and bradycardia which required surgical intervention.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.A visual inspection and an evaluation of all features of the device were performed following bwi procedures.Visual analysis revealed no damage nor anomalies on the device.Per the event, several tests were performed.The magnetic, electrical, temperature and force features were tested, and no issues were observed.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for lot 30787584l and no internal actions related to the complaint were found during the review.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) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The root cause of the adverse event remains unknown.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: 15693818
• MDR Text Key: 302688374
• Report Number: 2029046-2022-02685
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2023

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: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30787584L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/28/2022
• Supplement Dates Manufacturer Received: 12/20/2022; 02/01/2023
• Supplement Dates FDA Received: 01/19/2023; 02/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2022
• 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: PENTARAY NAV ECO 7FR, D, 2-6-2; UNK FUKUDA RF NEEDLE; UNK_CARTO 3; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female