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

Model Number D134804

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/18/2020

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)(6).

Event Description

It was reported that a (b)(6) female patient ((b)(6)) underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.During the procedure while ablating the left atrium (la), the anesthesiologist noted the patient¿s blood pressure was high.The ultrasound confirmed the patient had pericardial effusion.The physician noted the effusion wasn't detrimental to the patient at the time and the case was completed.After the ablation, the patient had a pericardiocentesis on which 600ml of fluid was removed.The patient was stable during the entire procedure, but medicine for their blood pressure was administered during the pericardiocentesis.The patient remained stable and was transferred to the post-anesthesia care unit (pacu).Patient stayed overnight for observation.The physician is not sure what may have caused the effusion.When labs were drawn, the patient¿s creatinine was high.There was a baseline effusion at the start of the procedure as noted on intracardiac echocardiography (ice).Transseptal puncture was done with a cook transseptal needle.There was no evidence of steam pop during the ablation, they did not receive any high force reading or high impedance reading during the ablation and tag indexes used as coloring option were all in the normal range.Standard flow settings for stsf were used.Ablation was done at 50 watts.The force visualization features used included graph, dashboard, vector and visitag.The parameters for stability used were 3 mm, 3 sec, 25%, 3 g; tag size 3mm.Since this event is life threatening and required 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 (b)(6) 2020, the bwi 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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On (b)(6) 2021, the product investigation was completed.It was reported that a 67-year-old female patient (92.5kg) underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.During the procedure while ablating the left atrium (la), the anesthesiologist noted the patient¿s blood pressure was high.The ultrasound confirmed the patient had pericardial effusion.The physician noted the effusion wasn't detrimental to the patient at the time and the case was completed.After the ablation, the patient had a pericardiocentesis on which 600ml of fluid was removed.The patient was stable during the entire procedure, but medicine for their blood pressure was administered during the pericardiocentesis.The patient remained stable and was transferred to the post-anesthesia care unit (pacu).Patient stayed overnight for observation.The physician is not sure what may have caused the effusion.When labs were drawn, the patient¿s creatinine was high.There was a baseline effusion at the start of the procedure as noted on intracardiac echocardiography (ice).Device evaluation details: the device was visually inspected and it was found in good normal conditions.Per the complaint, several tests were performed.A deflection test was performed and the catheter was found in specification.Then, magnetic and force sensor functionality were tested on carto 3 system and the catheter passed the test: no errors were observed.Also, smartablate stockert generator compatibility was tested and the catheter was found in good conditions.Finally, a cool flow pump was performed but it failed: the catheter was not irrigating correctly.Further investigation revealed that the catheter was occluded with reddish material at dome.Reddish material was also observed at the distal part of the irrigation tube.A manufacturing record evaluation was performed for the finished device 30433272m number, and no internal actions related to the reported complaint condition were identified.The customer complaint cannot be confirmed.The root cause of the irrigation issue cannot be determined at this moment.However, the irrigation issue could not be related to the adverse event.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.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; 33 technology drive; irvine CA 92618
• MDR Report Key: 11016202
• MDR Text Key: 222315212
• Report Number: 2029046-2020-01923
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2020

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 Expiration Date: 09/09/2021
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30433272M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 12/16/2020; 01/14/2021
• Supplement Dates FDA Received: 01/04/2021; 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; COOK TRANSSEPTAL NEEDLE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 92