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

Catalog Number	NS7TCJ8L174HS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	06/27/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that a patient underwent an atrial flutter right (r-afl) ablation procedure with a navistar¿ ds electrophysiology catheter.The patient suffered cardiac arrest and ultimately passed away.It was reported that an adverse event and death occurred during a case.They reported that during an atrial flutter case, as they were gaining access, the sedated patient's blood pressure dropped into the 70s and their oxygen saturation dropped down into the 80s before any biosense webster product was used.They reported that they were originally using mac anesthesia and then they switched to general anesthesia.The blood pressure remained low but stable.The anesthesiologist then intubated the patient.They reported that they then used a coronary sinus catheter from a different company and used our navistar¿ ds electrophysiology catheter.They then began mapping the tachycardia and then ablated the tachycardia.They reported that no steam pops or impedance spikes were noted.After ablation was completed and the bi-directional isthmus block was attained, the patient then displayed pulseless electrical activity and no blood pressure reading.They performed a transthoracic echocardiogram and there was no pericardial effusion noted.They reported that a code was called, cardiopulmonary resuscitation (cpr) was performed, epinephrine was given, and after 25 to 30 minutes they declared a time of death.They reported that after the procedure when the physician was asked as to what caused the death, the physician had no opinion.Additional information was received.Physician¿s opinion on the cause of this adverse event was that no malfunction noted.Transthoracic echocardiogram (tte) was done to confirm no pericardial effusion and the cpr.In physician¿s opinion, the cause of death was unknown for sure, his thought was right heart failure.Procedure was completed normally, no steam pop, no high temperatures on the catheter.After converting from flutter to sinus rhythm, the patient went pea (pulseless electrical activity) no blood pressure was noted.Cpr was performed, tte showed no effusion.
Additional Manufacturer Narrative
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 803.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.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial flutter right (r-afl) ablation procedure with a navistar¿ ds electrophysiology catheter.The patient suffered cardiac arrest and ultimately passed away.The bwi product analysis lab received the device for evaluation 31-jul-2023.The device evaluation was completed on 01-aug-2023.According to the information received, it was reported an adverse event using a navistar ds.The product was returned to biosense webster (bwi) for evaluation.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.Physician¿s opinion on the cause of this adverse event was that no malfunction noted.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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: NAVISTAR¿ DS ELECTROPHYSIOLOGY CATHETER
• Common Device Name: 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17379953
• Report Number: 2029046-2023-01568
• Device Sequence Number: 12307698
• Product Code: OAD
• UDI-Device Identifier: 10846835000627
• UDI-Public: 10846835000627
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P010068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/17/2025
• Device Catalogue Number: NS7TCJ8L174HS
• Device Lot Number: 30951919M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NON BWI ¿ CORONARY SINUS CATHETER; SMARTABLATE GENERATOR KIT-US
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 64 KG