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

Model Number D134804

Device Problems High Readings (2459); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 05/30/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade (ct) requiring a surgical intervention and prolonged hospitalization.It was reported during an afib case, a pericardial effusion (pe) was noticed.They reported that an impedance spike caused the physician to ¿look around¿.The pericardial effusion was confirmed by intracardiac echocardiography (ice).The medical intervention provided was a pericardiocentesis and 240ml of fluid was removed.The patient was reported to be in stable condition.The physician did not mention what they thought caused the pericardial effusion.The adverse event occurred on (b)(6) 2023.It was discovered during use of biosense webster inc.(bwi) products, post transseptal maneuver.The physician¿s opinion on the cause of this adverse event was that the physician is unsure.His best guess was that the appendage may have been poked by the wire, causing a small hole.Intervention provided was that pericardiocentesis was performed and multiple cardiac echos to check on the effusion.The patient's tube from pericardiocentesis may have become clogged, leading to a pericardial window being opened and a larger tube inserted.The patient remained in the hospital.Outcome of the adverse event was that the patient improved, with no new fluid around heart.The patient required extended hospitalization because of the adverse event due to opening of pericardial window, and continued monitoring.Patient has been there last two days, as opposed to being released on (b)(6).At the time of the call, the doctor was unsure what day the patient will be released.Relevant tests/laboratory data- sample of effusion fluid sent to lab, no indication of myxoma present.Generator information was a smartablate generator spare-us sn (b)(6) ref m490002 hw-rev 08.All force visualization features were used (graph, dashboard, vector, visitag).Visitag module was used, parameters for stability used was 2 mm, 3 sec, 25% over 3g of force.Additional filter used with the visitag was respiration.Tags were colored by impedance (custom range 5-10) to watch for abnormal change in impedance.Tag size was set to 3mm.Color options used prospectively was impedance.Transseptal puncture was not performed as patient had an existing intra-atrial hole from a prior afib procedure in 2019.Prior to noting the pe or ct, ablation was performed.A singular point on the posterior wall had a rise of ~20 ohms in impedance during ablation.Smartablate cut off power due to parameters set by physician to stop at 20 ohm change.No lesion on back wall was observed, and patient¿s pressure indicated pericardial effusion prior to this burn.No steam pop sound was observed.All other burns performed had a maximum impedance change of 13 ohms.The event believed to have occurred during transeptal, but there is no good indication of start of effusion.Some effusion was present at baseline.Irrigated catheter was used in the event, flow settings were not changed from standard 2 and 15.Impedance change cutoff was set to 20 ohms by physician preference.Smartablate did stop appropriately.This incident is not believed to be the cause of the effusion.Generator parameters was power control, 40 w 60 sec, impedance cut off 200 ohm or 20 ohm drop.Temp cutoff 45.Again, the effusion is believed to have occurred before the abnormal impedance value.However, values for this burn are as follows- 6.47 sec, wattage 39-41 md 40.Temp 20-23 md 20, impedance 113-133 delta -20 ohms.4-41 grams of force, average 15.94 g*sec, f' n/a.

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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade (ct) requiring a surgical intervention and prolonged hospitalization.It was reported during an afib case, a pericardial effusion (pe) was noticed.They reported that an impedance spike caused the physician to ¿look around¿.The pericardial effusion was confirmed by intracardiac echocardiography (ice).The medical intervention provided was a pericardiocentesis and 240ml of fluid was removed.The patient was reported to be in stable condition.The physician did not mention what they thought caused the pericardial effusion.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no impedance issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.In addition, no device malfunction was reported, 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.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 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17209613
• MDR Text Key: 317987780
• Report Number: 2029046-2023-01391
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 31028030L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2023
• 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: SMARTABLATE GENERATOR SPARE-US.; UNK_CARTO 3.
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 91 KG