MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Model Number	NS7TCFL174HS
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	11/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an unknown male patient underwent an atrial fibrillation (afib) procedure with a navistar¿ electrophysiology catheter.The patient suffered av heart block requiring surgical intervention.A transient av block occurred during ablation at the slow in a procedure of nrt.The event occurred thirty minutes after using the navistar catheter.After six minutes, av connection returned spontaneously.After ablation of the slow, a transient av block occurred in the procedure (for about six minutes).With a distance of 20 mm from his, the ablation time was about twenty seconds, and there was no problem with the resistance value at 20w to 25w.At the end of the study, the pq returned to normal at 150ms, but the patient was discharged from the room with a temporary insertion from the neck.Non-serious (moderate/minimal).The causality with the product was unknown.It is not considered that there was a defect in the product.No abnormalities were observed before or during use of the products.At a later date, the patient developed av block and a permanent pacemaker was inserted.Details of health injury: transient av block¿av block.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.
Additional Manufacturer Narrative
(b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).
Additional Manufacturer Narrative
On 27-dec-2021, bwi received additional information regarding the event.This adverse event was discovered during use of biosense webster products.The physician commented that there was no malfunction on the catheter.During the procedure, the medical intervention provided was a temporary pacemaker that was inserted from the neck.The patient outcome of the adverse event is improved.Generator information: smartablate.The bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.Device evaluation details: the device was returned to biosense webster for evaluation.Bwi conducted a visual inspection and an evaluation of all features of the catheter.Visual analysis of the returned device revealed that no damage or anomalies were observed on the navistar.Per the event, several tests were performed.The magnetic, electrical, and temperature features were tested, and no issues were observed.In addition, the product was deflecting correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device 30450135m number, and no internal actions related to the reported complaint condition were identified.No malfunction was observed during the product analysis.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 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: NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING
• 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: 12897994
• Report Number: 2029046-2021-02085
• Device Sequence Number: 14653208
• Product Code: DRF
• UDI-Device Identifier: 10846835000610
• UDI-Public: 10846835000610
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P990025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2022

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: 10/04/2023
• Device Model Number: NS7TCFL174HS
• Device Catalogue Number: NS7TCFL174HS
• Device Lot Number: 30450135M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 12/27/2021
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2020
• 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: SMARTABLATE GENERATOR
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Male