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

Model Number D134805

Device Problem Signal Artifact/Noise (1036)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2022

Event Type  malfunction  

Event Description

It was reported that a female patient (approximately 70 years old) underwent a paroxysmal atrial fibrillation (afib) ablation procedure with two (2) thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a cardiac tamponade requiring a pericardiocentesis.A pericardial effusion was seen during the procedure via soundstar catheter.The procedure was aborted and the physician performed a pericardiocentesis at the time of the call.The physician believes the effusion occurred when he was attempting to get out the coronary sinus (cs).He was running into a eustachian valve and was having troubles.He first attempted with the bwi cs but then finally got out with his ij split 14 pole catheter.A pericardiocentesis was performed on the patient and then they were sent to the icu.It was also reported that electrogram noise/saturation displayed on both the carto 3 and recording system ecg signals.The ablation cable was replaced without resolution.The catheter was replaced and the issue resolved.The carto 3 system is operating per specs and is not responsible for the product issue.It is unknown if the patient required extended hospitalization because of the adverse event, they were sent to the intensive care unit (icu) for further evaluation.A transseptal puncture performed but we believe that we slipped through a patent foramen ovale (pfo).No ablation was performed.The event was noticed during the mapping of the left atrium (la).Pressures dropped and he investigated with ice and uncovered the effusion.It is believed to have happened before mapping though.Irrigation was set to low flow of 2ml the entire time.The correct catheter settings were selected on the generator and the pump switching from low to high was n/a as no ablation was performed.No errors were observed.All systems were functioning properly.Force visualization features used were graph, dashboard & vector.Noise was observed on all ecg including the anesthesia cart and carto/recording system.The medical team could slightly make out the qrs on the recording system but it would come and go for a couple minutes while the issue was isolated.The ablation catheter was the cause of the noise and it was noticed as the catheter was going up into the patient¿s heart.Conservatively the thermocool® smart touch® sf bi-directional navigation catheter was in the cs.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

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

On 19-apr-2022, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a female patient (approximately 70 years old) underwent a paroxysmal atrial fibrillation (afib) ablation procedure with two (2) thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a cardiac tamponade requiring a pericardiocentesis.Device evaluation details: visual analysis revealed no damage or anomalies on the device.An electrical test was performed, and no electrical issues were found.A manufacturing record evaluation was performed for the finished device 30732207l number, and no internal action was found during the review.The electrical issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instructions for use contain the following recommendation: ecg noise is typically generated as the result of the improper connection of the body surface ecg patch to the patient.This noise is the most significant during ablation.To resolve this situation, verify the proper connection.It is recommended to turn off the notch filter for this verification.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 14115843
• MDR Text Key: 290528968
• Report Number: 2029046-2022-00807
• 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: 05/09/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2023
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30732207L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/14/2022
• Initial Date FDA Received: 04/14/2022
• Supplement Dates Manufacturer Received: 04/14/2022; 04/19/2022
• Supplement Dates FDA Received: 04/14/2022; 05/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2022
• 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 3 SYSTEM; RECORDING SYSTEM; SOUNDSTAR CATHETER; THERMOCOOL SMARTTOUCH; UNSPECIFIED PUMP
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Female