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

Catalog Number D134805

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Tamponade (2226)

Event Date 12/05/2019

Event Type  Injury  

Manufacturer Narrative

Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.A manufacturing record evaluation was performed for the finished device with lot number 30262222m, and no internal actions related to the reported complaint condition were identified.Manufacturer's reference # (b)(4).

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 and suffered a cardiac tamponade requiring pericardiocentesis.During the procedure, the catheters were inserted, a transseptal puncture was performed and before merge, the thermocool® smart touch® sf bi-directional navigation catheter, the lasso® nav eco variable catheter, and soundstar eco 8fg ultrasound catheter were connected to the patient interface unit (piu) and error 7 (current leakage error) occurred.Temperature display of the ablation catheter was over 170°c and an alert was heard.When all catheters were removed, the issue resolved.The catheters were connected one by one and the issue was not reproduced.Error 7 and ablation catheter temperature display became abnormal again after a while.The system was rebooted; however, the issue did not improve.All the catheters were removed again and connected one by one and the issue did not improve.However, when the ablation catheter was connected, there was alert of ¿force accuracy is reduced¿.Therefore, the thermocool® smart touch® sf bi-directional navigation catheter was changed, and the issue was resolved.The procedure continued.Manual merge was attempted by the pentaray nav high-density mapping eco catheter and lasso® nav eco variable catheter and soundstar eco 8fg ultrasound catheter was displayed on the carto® 3 system screen; however, the pentaray nav high-density mapping eco catheter was not displayed.Connection of pentaray nav high-density mapping eco catheter to 20a and lasso® nav eco variable catheter to 20b was changed to port, but the issue continued.When the port was turned, error 116 (magnetic sensor error) was displayed.Therefore, the pentaray nav high-density mapping eco catheter was changed, and the issue resolved.The procedure continued and during ablation for left pulmonary vein isolation (pvi) of the roof, the patient¿s blood pressure dropped.A cardiac tamponade was discovered and pericardiocentesis was performed and interrupted the procedure.There¿s no information regarding extended hospitalization, patient¿s outcome or physician causality opinion.

Manufacturer Narrative

On (b)(6)2019 , the biosense webster, inc.Product analysis lab received the device for evaluation, and it was noted that upon initial visual inspection, no visual damages or anomalies were observed.On (b)(6)2020, additional information was provided, and it was noted that the patient was male, therefore, section a3.Sex has been populated.Investigation summary- it was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered a cardiac tamponade requiring pericardiocentesis.During the procedure, the catheters were inserted, a transseptal puncture was performed and before merge, the thermocool® smart touch® sf bi-directional navigation catheter, the lasso® nav eco variable catheter, and soundstar eco 8fg ultrasound catheter were connected to the patient interface unit (piu) and error 7 (current leakage error) occurred.Temperature display of the ablation catheter was over 170°c and an alert was heard.When all catheters were removed, the issue resolved.The catheters were connected one by one and the issue was not reproduced.Error 7 and ablation catheter temperature display became abnormal again after a while.The system was rebooted; however, the issue did not improve.All the catheters were removed again and connected one by one and the issue did not improve.However, when the ablation catheter was connected, there was alert of ¿force accuracy is reduced¿.Therefore, the thermocool® smart touch® sf bi-directional navigation catheter was changed, and the issue was resolved.The device was visually inspected, and it was found in good condition.The magnetic sensor and force sensor were tested on carto and the catheter was properly visualized and no errors were observed.The catheter was working properly, and the force values were observed within specifications.Electrical, generator and the temperature testing were performed on the catheter and it was found that the values for the electrical, generator, temperature and impedance were observed within specifications.The irrigation and deflection tests were performed and were found within specification.The catheter was irrigating and deflecting correctly.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint were identified.The customer complaint cannot be confirmed.The catheter passed all specifications.The root cause of the adverse event remains unknown.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.Manufacturer's reference # pc-000615365.

• 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: 9532471
• MDR Text Key: 188859279
• Report Number: 2029046-2019-04075
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2020
• Device Catalogue Number: D134805
• Device Lot Number: 30262222M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2019
• Date Manufacturer Received: 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; LASSO NAV 2515,12P SPLITHANDLE; PENTARAY NAV ECO 7FR, D, 2-6-2; PENTARAY NAV ECO 7FR, D, 2-6-2; SOUNDSTAR ECO SMS 8F CATHETER; THMCL SMTCH SF BID, TC, D-F
• Patient Outcome(s): Life Threatening; Required Intervention