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 08/17/2022

Event Type  Injury  

Event Description

It was reported that a 69-year-old male patient (110 kgs) underwent a paroxysmal atrial fibrillation (afib)ablation procedure with a navistar® rmt thermocool® electrophysiology catheter and a webster ® cs catheter with ez steer® thechnology and auto id.The patient suffered cardiac tamponade requiring pericardiocentesis and prolonged hospitalization.It was reported that after the ablation, the patient suffered a pericardial effusion.It was discovered while the patient was still on the procedure table, after catheter removal, using transthoracic echo.The caller was uncertain if the patient's blood pressure was affected.A pericardiocentesis was ongoing at the time of the call.The patient remained stable.The physician did not indicate that they believed biosense webster, inc.Products contributed to the patient event.Additional information was received.This adverse event was discovered post use of biosense webster products.Pericardiocentesis was performed, no other intervention necessary.The patient¿s current condition is unknown, but patient went home.Patient stayed in hospital for 2 days, would have only been here for the day if procedure went according to plan.Transseptal puncture was performed.There was no known steam pop.The biosense webster representative is not sure when the event occurred, as it was noticed after the ablation was over.The biosense webster representative sent all catheters back because they were not sure which one would be under investigation at the time and wanted to cover all bases.Since sending them back, the physician has stated she suspects she perforated with the coronary sinus catheter at the beginning of the case, but they were never able to get a definitive diagnosis as the chest was never opened.The biosense webster representative does not know which coronary sinus catheter is the suspected device.They think both were used in an attempt to get the coronary sinus access but can not remember the order they were used in.Conservatively the bwi webster ® cs catheter with ez steer® thechnology and auto id and the a navistar® rmt thermocool® electrophysiology catheter were assessed as mdr reportable as ¿the physician has stated she suspects she perforated with the coronary sinus catheter at the beginning of the case, but they were never able to get a definitive diagnosis as the chest was never opened.¿ therefore, it is difficult to determine which device contributed to the event.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 29-aug-2022.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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The device evaluation was completed on 14-sep-2022.It was reported that a 69-year-old male patient (110 kgs) underwent a paroxysmal atrial fibrillation (afib)ablation procedure with a navistar® rmt thermocool® electrophysiology catheter and a webster ® cs catheter with ez steer® thechnology and auto id.The patient suffered cardiac tamponade requiring pericardiocentesis and prolonged hospitalization.The product was returned to biosense webster for evaluation.Bwi conducted a general inspection through the visual inspection and all features of the catheter tests.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the navistar rmt thermocool catheter.Per the event, several tests were performed.Visual, electric, and temperature features were tested, and no error was observed.In addition, the product was irrigating correctly.The magnetic sensors were measured, and all were within specification.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.No malfunction was observed during the product analysis.The instructions for use states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) during an internal review on (b)(6) 2022, a correction was noted to the 3500a initial as we reported as a concomitant product ¿reprocessed 6fr cs, d, 10 pole¿; however, on 06-sep-2022, clarification had been received correcting this device to ¿reprocessed 6fr cs, f, 10 pole¿.Therefore, updated the ¿d10.Concomitant medical products and therapy dates¿ field.

• 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; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15408214
• MDR Text Key: 299767870
• Report Number: 2029046-2022-02207
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835008500
• UDI-Public: 10846835008500
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NR7TCSIY
• Device Catalogue Number: NR7TCSIY
• Device Lot Number: 30622368M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2021
• 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: BI DIR 7FR DEF CS,F-J,12 PIN.; PENTARAY NAV ECO 7FR, D, 2-6-2.; REPROCESSED 6FR CS, D, 10 POLE.; REPROCESSED 6FR CS, F, 10 POLE.; UNK_SMARTABLATE GENERATOR.
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 110 KG