MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVI-STAR THERMO-COOL ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number NI75TCFH

Device Problems High Readings (2459); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Cardiac Tamponade (2226); No Code Available (3191)

Event Date 10/27/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6)."no code available" is being used to represent the surgical intervention.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 male patient underwent a ventricular extrasystole (ves) ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.After confirmation with intracardiac signals that the ves were coming from the left ventricle, the physician decided to perform a transseptal access to go in the left ventricle.After usual transseptal puncture, the physician inserted the fixed sheath across the puncture, removed the needle and then inserted the ablation catheter through the needle.Everything seemed normal, with good signals measures; therefore, the physician decided to start the mapping of the ves.After approximately 10 min, the physician noticed unusually high impedance value on the catheter.The impedance was above the cut-off value; however, since no ablation was intended, the system did not have to stop any ablation.Pericardial effusion was then confirmed by intracardiac echography (ice).Cardiac tamponade protocol was launched and pericardiocentesis was performed to drain the blood from the pericardial space.After approximately 1 hour draining the blood and reinjecting it into the patient, the bleeding did not stop.The patient was moved to cardiac surgery to get the perforation sutured.It seemed the surgery was successfully, and the patient was stable.Prolonged hospitalization was required.Physician¿s causality opinion was not provided; however, it was reported that the tamponade could have possibly occurred during the transseptal puncture.The generator was used in temperature control mode, with a temperature cut off: 95°c., max power: 35w and impedance cut-off: 250 ohm.The temperature noticed on generator during mapping with ablation catheter was in normal values around 37°c.The impedance noticed on generator during mapping with ablation catheter was high, rising until 280 ohms, between 160 and 250 in average.The catheter irrigation was set as follows: high flow: 20ml/min, low flow 2ml/min, pre rf-time: 2s, post rf-time:2s, low fluid warning: 100ml.No error messages were reported in any equipment.This event is being conservatively reported under the bwi ablation catheter since it has been manipulated inside the patient's body for mapping when the adverse event was discovered; therefore, its contribution with the adverse event occurrence cannot be excluded.High impedance is not an mdr-reportable issue.However, since the cardiac tamponade is life threatening and required intervention and prolonged hospitalization 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 12/11/2020, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a male patient underwent a ventricular extrasystole (ves) ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.After confirmation with intracardiac signals that the ves were coming from the left ventricle, the physician decided to perform a transseptal access to go in the left ventricle.After usual transseptal puncture, the physician inserted the fixed sheath across the puncture, removed the needle and then inserted the ablation catheter through the needle.Everything seemed normal, with good signals measures; therefore, the physician decided to start the mapping of the ves.After approximately 10min, the physician noticed unusually high impedance value on the catheter.The impedance was above the cut-off value; however, since no ablation was intended, the system did not have to stop any ablation.Pericardial effusion was then confirmed by intracardiac echography (ice).Cardiac tamponade protocol was launched and pericardiocentesis was performed to drain the blood from the pericardial space.After approximately 1 hour draining the blood and reinjecting it into the patient, the bleeding did not stop.The patient was moved to cardiac surgery to get the perforation sutured.It seemed the surgery was successfully, and the patient was stable.Prolonged hospitalization was required.Device evaluation details: the device was visually inspected, and it was found in good conditions.The temperature and electrical features were tested, and no issues were observed.In addition, the catheter was deflecting and irrigating correctly.Then, magnetic sensor functionality was tested on carto and the catheter failed, error 105 was observed.A failure analysis was performed, the catheter was dissected, and the sensor values were found within specifications, with this information, the failure can be attributed to a potential pc board failure.A manufacturing record evaluation was performed for the finished device 30377448m number, and no internal action was found during the review.The root cause of the adverse event remains unknown.The root cause of the pc board failure cannot be determined.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: NAVI-STAR THERMO-COOL ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 10864974
• MDR Text Key: 217663264
• Report Number: 2029046-2020-01768
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835000566
• UDI-Public: 10846835000566
• 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: 10/28/2020

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 Model Number: NI75TCFH
• Device Catalogue Number: NI75TCFH
• Device Lot Number: 30377448M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/18/2020
• Supplement Dates Manufacturer Received: 12/11/2020
• Supplement Dates FDA Received: 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; DECANAV; PENTARAY NAV ECO; SMARTABLATE GENERATOR; UNK_TRANSEPTAL NEEDLE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention