MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. NAVISTAR RMT THERMOCOOL ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number NR7TCSIY

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/30/2020

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 ref.# (b)(4).

Event Description

It was reported that a patient underwent cardiac ablation procedure for atrial fibrillation (afib) with navistar® rmt thermocool® electrophysiology catheter and suffered cardiac tamponade requiring surgical intervention.It was reported that a single transseptal sheath was paced across.The physician mapped the left atrium but could not maneuver the catheter to the left superior pulmonary vein.The physician replaced it with a rmt catheter and could not go posterior in the chamber.It was then noticed that the patient¿s blood pressure dropped to 70mmhg.Through the accunav and transthoracic echo a pericardial effusion was noted.The acunav was in the right atrium.No ablations had been performed.A pericardiocentesis was performed and the patient was transferred to surgery.The surgeon found a hole in the roof of the left atrium.It is believed that this occurred during the transseptal part of the procedure.The patient is stable and recovering.The event is conservatively reported under the ablation catheter.

Manufacturer Narrative

On (b)(6) 2021, the bwi product analysis lab received the complaint device for evaluation.The product 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 ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent cardiac ablation procedure for atrial fibrillation (afib) with navistar® rmt thermocool® electrophysiology catheter and suffered cardiac tamponade requiring surgical intervention.It was reported that a single transseptal sheath was paced across.Device evaluation details: the device evaluation has been completed.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 irrigating correctly.Then, magnetic sensor functionality was tested on carto and the catheter failed the test since the icon was observed in a reverse position.A failure analysis was performed, the catheter was dissected, and the sensor values were found within product specification, with this information, the failure related with reverse icon can be attributed to a potential pc board failure.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint cannot be confirmed.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.The root cause of the reverse icon or pc board failure identified during product evaluation cannot be determined; potential cause traced to the component failure (circuit board/pc board).Additionally, during product evaluation/testing, the lot number was identified by electronically erasable programmable read only memory (eeprom) as 30410835m.As such, field d4.Lot number has been populated.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: NAVISTAR RMT THERMOCOOL 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: 11074749
• MDR Text Key: 223799661
• Report Number: 2029046-2020-01984
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835008500
• UDI-Public: 10846835008500
• 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: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2023
• Device Model Number: NR7TCSIY
• Device Catalogue Number: NR7TCSIY
• Device Lot Number: 30410835M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2021
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACUNAV 8F-90; PENTARAY NAV ECO 7FR, F, 2-6-2; SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US; ACUNAV 8F-90; PENTARAY NAV ECO 7FR, F, 2-6-2; SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US
• Patient Outcome(s): Life Threatening; Required Intervention