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 Cardiac Tamponade (2226)

Event Date 11/09/2021

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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 a patient underwent an atrial fibrillation (afib) ablation with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and suffered cardiac tamponade (ct) requiring pericardiocentesis.It was reported that after an atrial fibrillation case had completed, a cardiac perforation was noticed in the patient.The reporter was unable to provide any information as to how the incident had occurred.The cardiac perforation was confirmed via intracardiac ultrasound.The medical intervention provided was a pericardiocentesis, and it is unknown how much fluid was removed.The patient was reported to be in stable condition.It was also reported that there was no impedance data displayed on the carto 3 system.The reporter replaced the serial (b)(4) cable, connecting from the carto 3 system workstation to the smartablate remote, and the issue resolved.The procedure continued.Additional information was received on (b)(6) 2021.This adverse event was discovered post use of biosense webster products.The physician did not provide a causality opinion for the cause of this adverse event.The patient fully recovered with no residual effects.It is unknown if the patient required extended hospitalization because of the adverse event.A transseptal puncture was performed with a st jude brk (details unknown).Prior to noting the ct, ablation was performed.There was no evidence of a steam pop.An irrigated catheter was used in the event and the flow settings were: stsf default settings.The correct catheter settings were selected on the generator, and the pump was switching from low to high flow during ablation.No error messages were observed on the biosense webster equipment during the procedure.Force visualization features: graph, dashboard, vector, and visitag with parameters for stability set at: surpoint settings (3, 3, 25% 3g); 3mm tag size.No additional filter used with the visitag.Color options used prospectively was tag index.Since the event (cardiac tamponade) is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure and it required 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.The no impedance was assessed as not mdr reportable.Since the impedance is not displayed, the device can¿t be used.The most likely consequence is an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The communication issue - carto/external system issue was assessed as not mdr reportable.It is highly detectable.The potential risk is low.

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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 a patient underwent an atrial fibrillation (afib) ablation with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and suffered cardiac tamponade (ct) requiring pericardiocentesis.It was reported that after an atrial fibrillation case had completed, a cardiac perforation was noticed in the patient.The reporter was unable to provide any information as to how the incident had occurred.The cardiac perforation was confirmed via intracardiac ultrasound.The medical intervention provided was a pericardiocentesis, and it is unknown how much fluid was removed.The patient was reported to be in stable condition.It was also reported that there was no impedance data displayed on the carto 3 system.The reporter replaced the serial (b)(4) cable, connecting from the carto 3 system workstation to the smartablate remote, and the issue resolved.The procedure continued.Additional information was received on (b)(6) 2021.This adverse event was discovered post use of biosense webster products.The physician did not provide a causality opinion for the cause of this adverse event.The patient fully recovered with no residual effects.It is unknown if the patient required extended hospitalization because of the adverse event.A transseptal puncture was performed with a st jude brk (details unknown).Prior to noting the ct, ablation was performed.There was no evidence of a steam pop.An irrigated catheter was used in the event and the flow settings were: stsf default settings.The correct catheter settings were selected on the generator, and the pump was switching from low to high flow during ablation.No error messages were observed on the biosense webster equipment during the procedure.Force visualization features: graph, dashboard, vector, and visitag with parameters for stability set at: surpoint settings (3, 3, 25% 3g); 3mm tag size.No additional filter used with the visitag.Color options used prospectively was tag index.Since the event (cardiac tamponade) is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure and it required 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.The no impedance was assessed as not mdr reportable.Since the impedance is not displayed, the device can¿t be used.The most likely consequence is an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The communication issue - carto/external system issue was assessed as not mdr reportable.It is highly detectable.The potential risk is low.

• 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: 12931774
• MDR Text Key: 285248554
• Report Number: 2029046-2021-02111
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2021

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: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 12/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: SMA SCOM RECORD/CARTO CABLE 5M.; SMARTABLATE GENERATOR KIT-US.; UNK ST. JUDE BRK¿ TRANSSEPTAL NEEDLE.
• Patient Outcome(s): Required Intervention; Life Threatening