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

Model Number D134805

Device Problems Low impedance (2285); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/10/2021

Event Type  Injury  

Manufacturer Narrative

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 female patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis, surgical intervention and prolonged hospitalization.It was reported that during the procedure, a pericardial effusion was noticed after the physician reported a steam pop.The physician requested a review of the visitags and a drop of 92 to 81 impedance was identified.No peaking patterns were seen.The setting used was high-power short-duration passes with 10-15 sec only.Perforation was on the roof of the superior vein.The reporter stated that there was a drop in blood pressure in the patient.The pericardial effusion was confirmed by intracardiac echocardiography (ice).The medical intervention provided was a pericardiocentesis and no specific value was provided since the fluid was being reinfused.The patient was reported to be in stable condition but sedated on a vent and being moved to surgery.Additional information was received on the event.The adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event was the steam pop, high power, low impedance on superior aspect of the ridge of the left superior pulmonary vein.Intervention provided was a pericardiocentesis and chest compressions.Patient outcome of the adverse event: was that the patient went to surgery, patient survived - positive outcome.As of (b)(6) 2021, the patient was in a cardiac stepdown unit recovering well.The patient required extended hospitalization because of the adverse event.Required cardio thoracic surgery and stay in the hospital.On telemetry unit as of (b)(6) 2021.A transseptal puncture was performed with a st.Jude medical ¿ brk xs.Prior to noting the cardiac tamponade, ablation was performed.The event occurred during the ablation phase.An irrigated catheter was used in the event and the flow setting: 15 ml/minute.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 used: graph, dashboard, vector & visitag with the visitag module parameters for stability: range 1.5 mm, time 3 seconds; fot 25% for 3 grams, visitag size 2mm and no additional filter was used with the visitag.Color options were used prospectively: other ¿ imp ¿ 5-10 ohms.Generator parameters: power control, temperature and power cut off were at device default.The noted temperature, impedance and power at the time of steam pop: from picture taken of the visitag statistics for lesion number 64, believed to be the one with the steam pop: temp ¿ min 21.3, max 22.3, avg 21.6, imp.¿ initial 92, change was drop of 11, power ¿ min 7, max 52, avg 49, time ¿ 00:13 & force ¿ min 8, max 24, avg 16.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.The low impedance issue was assessed as not mdr reportable.Since the generator stopped delivering radio frequency, the most likely consequence was an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.

Manufacturer Narrative

It was reported that a female patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis, surgical intervention and prolonged hospitalization.It was reported that during the procedure, a pericardial effusion was noticed after the physician reported a steam pop.The physician requested a review of the visitags and a drop of 92 to 81 impedance was identified.No peaking patterns were seen.The setting used was high-power short-duration passes with 10-15 sec only.Perforation was on the roof of the superior vein.The reporter stated that there was a drop in blood pressure in the patient.The pericardial effusion was confirmed by intracardiac echocardiography (ice).The medical intervention provided was a pericardiocentesis and no specific value was provided since the fluid was being reinfused.The patient was reported to be in stable condition but sedated on a vent and being moved to surgery.Additional information was received on the event.The adverse event was discovered during use of biosense webster products.Intervention provided was a pericardiocentesis and chest compressions.Patient outcome of the adverse event: was that the patient went to surgery, patient survived - positive outcome.As of 17-nov-2021, the patient was in a cardiac stepdown unit recovering well.The patient required extended hospitalization because of the adverse event.Required cardio thoracic surgery and stay in the hospital.On telemetry unit as of 17-nov-2021.The device evaluation was completed on 14-dec-2021.The product involved: thermocool smarttouch sf (bidirectional) catheter.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and an evaluation of all features of the catheter.Visual analysis of the returned product revealed that no damage or anomalies were observed on the thermocool smarttouch sf (bidirectional) 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 catheter batch number, and no internal actions were identified.As part of bwi¿s quality process, all catheters are manufactured, inspected, and released to approved specifications.No malfunction was observed during the product analysis.The instructions for use states that it is important to carefully follow the warning and precautions.- it is important to carefully follow the power titration procedure as specified in the instructions for use.Too rapid an increase in power during ablation may lead to perforation caused by steam pop.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the catheter 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).

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 10-dec-2021.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).

• 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 ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12946049
• MDR Text Key: 281837795
• Report Number: 2029046-2021-02124
• 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,Followup,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30634357L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2021
• 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: NON BWI-ST. JUDE MEDICAL ¿ BRK XS; SMARTABLATE GENERATOR SPARE-US; SMARTABLATE PUMP SPARE-US; UNK_CARTO 3
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Female