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 Problems Fever (1858); Cardiac Tamponade (2226)

Event Date 05/11/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A device history record evaluation was performed for the finished device 30719837l number, and no internal actions related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that an unknown patient underwent a premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.Cardiac tamponade occurred at the right heart system; it was as small, cardiac drainage was conducted as intervention and 50ml of fluid was aspirated from the right heart system.Atrial septal puncture was not performed.Ablation was performed before pericardial effusion or tamponade was identified at 40w.Steam pop was not confirmed.The irrigation catheter¿s flow rate setting was as per the basic setting.The physician's opinions on the relationship between the event and the product is that it was not a complication of the product.The physician's judgment on health injury is that it was non-serious (moderate/minor).No error messages were observed on biosense webster equipment during the procedure.Dashboard; vector; and visitag force visualization features were used.Tag index color option were used prospectively.The physician commented that the adverse event was not related with the bw product.After cardiac drainage conducted for right sided heart, the patient¿s condition got stable with no problems.The patient had a slight fever, but it was not pericarditis.The target pvc has also terminated.The physician confirmed the adverse event was not related to bw product.The progress was good and there was no problem.The patient experienced slight fever, but it wasn't pericarditis.The target pvc was also stopped.There was no error/issue/failure occurred with 8.5f sheath with curve viz smc (d138501).Since the vizigo sheath was used in the patient body when cardiac tamponade was developed, we requested to create additional ip for vizigo sheath.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

On 6-jun-2022, additional information received indicating the patient did not require extended hospitalization because of the adverse event.The patient¿s condition was reported as improved.The adverse event occurred during the procedure.The correct catheter settings were selected on the generator and the pump was switching from low to high flow during ablation.No additional visitag filters were used.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14598961
• MDR Text Key: 293339269
• Report Number: 2029046-2022-01185
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2023
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30719837L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/17/2022
• 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: CARTO VISITAG MODULE.; JPN CARTO 3 SYSTEM.; UNKNOWN GENERATOR.; UNKNOWN PUMP.; VIZIGO SHEATH.
• Patient Outcome(s): Required Intervention; Life Threatening