MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number BNI75TCDFH

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 09/16/2021

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 an (b)(6) female patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with an ez steer¿ thermocool® nav bi-directional catheter and the patient suffered cardiac tamponade requiring pericardiocentesis.During a premature ventricular contraction (pvc) / ventricular tachycardia idiopathic case, a pericardial effusion was noticed.This adverse event was discovered during use of biosense webster products.The pericardial effusion was discovered and confirmed with ultrasound by the physician.Medical intervention provided was a "drain" and 300 ml of fluid was removed.The procedure was aborted and not completed.The patient was reported to be in stable condition.The physician¿s opinion on the cause of this adverse event: is that it was caused by a non bwi product.The physician states the event occurred during coronary sinus (cs) venogram.Patient outcome from the adverse event was reported as recovered.It is unknown if the patient required extended hospitalization because of the adverse event.Generator used was a smartablate.Transseptal puncture was performed.Prior to noting the cardiac tamponade, ablation had not been performed.Irrigated catheter was used in the event with flow setting at 17/30 flow rates.The correct catheter settings were selected on the smartablate generator.

Manufacturer Narrative

On 14-oct-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

The device evaluation was completed on 5-nov-2021.It was reported that an 82-year-old female patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with an ez steer¿ thermocool® nav bi-directional catheter and the patient suffered cardiac tamponade requiring pericardiocentesis.During a premature ventricular contraction (pvc) / ventricular tachycardia idiopathic case, a pericardial effusion was noticed.This adverse event was discovered during use of biosense webster products.The pericardial effusion was discovered and confirmed with ultrasound by the physician.Medical intervention provided was a "drain" and 300 ml of fluid was removed.The procedure was aborted and not completed.The patient was reported to be in stable condition.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation.Bwi conducted a visual inspection and an evaluation of all features of the catheter.Visual analysis of the returned product revealed that no damage or anomalies were observed on the ez steer¿ thermocool® nav bi-directional catheter.Per the event, several tests were performed.The magnetic, temperature features were tested, and no issues were observed.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device [30531860m] number, and no internal actions related to the reported complaint condition 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 instruction 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).

• Brand Name: EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL 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 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12602428
• MDR Text Key: 279529524
• Report Number: 2029046-2021-01718
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835003338
• UDI-Public: 10846835003338
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2021

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: 04/21/2024
• Device Model Number: BNI75TCDFH
• Device Catalogue Number: BNI75TCDFH
• Device Lot Number: 30531860M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2021
• Initial Date FDA Received: 10/09/2021
• Supplement Dates Manufacturer Received: 10/14/2021; 11/05/2021
• Supplement Dates FDA Received: 10/19/2021; 11/30/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/22/2021
• 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: SMARTABLATE GENERATOR KIT-US
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female