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 Asystole (4442)

Event Date 02/15/2022

Event Type  Injury  

Event Description

It was reported that a female patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered a sinus node injury requiring an external pacemaker to be implanted and prolonged hospitalization.During use of biosense webster products, the patient had a sinus node injury.A temporary external pacemaker was implanted, and the patient was followed up in the ward.The physician commented that before replacing the patch in the 3d, superior vena cava isolation (svci) was checked under fluoroscopy at the discretion of the physician, however the sinus node stopped pulsating.The physician commented that the catheter had been moved during the procedure.The physician¿s opinion on the cause of this adverse event was that it was procedure related.The physician considered that the cause was movement of the ablation catheter.The patient outcome of the adverse event was reported as improved.The patient still has the temporary external pacemaker at the time of reporting.The patient required extended hospitalization because of the external pacemaker which was implanted temporarily.It was also reported that there was a 1006 error observed after the procedure was started.It was replaced with an alternative equipment and the procedure was continued and completed.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

Initial reporter phone: (b)(6).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 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 information was received, and it was reported that the patient was discharged from the hospital after the return of the patient's own pulse was confirmed.This adverse event was discovered during use of biosense webster products.The patient had temporally external pacemaker until her own cardio pace came back; therefore, as previously reported, the patient required extended hospitalization.A smartablate generator with serial number (b)(6) was used.Therefore, the concomitant product section was updated.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 19-apr-2022.It was reported that a female patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered a sinus node injury requiring an external pacemaker to be implanted and prolonged hospitalization.During use of biosense webster products, the patient had a sinus node injury.A temporary external pacemaker was implanted, and the patient was followed up in the ward.The physician commented that before replacing the patch in the 3d, superior vena cava isolation (svci) was checked under fluoroscopy at the discretion of the physician, however the sinus node stopped pulsating.The physician commented that the catheter had been moved during the procedure.It was also reported that there was a 1006 error observed after the procedure was started.It was replaced with an alternative equipment and the procedure was continued and completed.Device evaluation details: the product was returned to biosense webster for evaluation.Bwi conducted a general inspection through the visual inspection and all features of the catheter tests.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the thermocool® smart touch® sf bi-directional navigation catheter.Per the event, several tests were performed.The magnetic, 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 the finished device 30681071l number, and no internal actions related to the complaint were found during the review.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No malfunction was observed during the product analysis.The instructions 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.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13768317
• MDR Text Key: 290076291
• Report Number: 2029046-2022-00539
• 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
• Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30681071L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2021
• 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 WITH CARTO MERGE; PENTARAY NAV ECO 7FR, D, 2-6-2; SMARTABLATE GEN. KIT (JAPAN); SOUNDSTAR ECO SMS 8F CATHETER
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Female