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

Model Number	NS7TCDL174HS
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	06/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an 67-year-old female patient (49 kg) underwent an atrioventricular nodal reentry tachycardia (avnrt) ablation procedure with a navistar¿ electrophysiology catheter and the patient suffered heart block requiring surgical intervention and prolonged hospitalization.During an avnrt procedure, during slow pathway ablation, av block occurred.Spontaneous pulse was developed only in the a wave.His electrical signal was not visible.Av block was observed in sinus immediately after the junction which was not fast continued.Therefore, ablation was immediately stopped, but autologous pulse did not return.Temporary pacemaker implantation was performed, and the patient was moved out of the room.It was decided to check whether the patient developed an autologous pulse in the ward.The patient was monitored until the next morning.The patient¿s own pulse did not return, and a pacemaker was implanted.The doctor commented that the patient¿s impulse conducting system may have been weak due to the patient's pre-operative history of atrioventricular block (type 1).The physician¿s opinion on the cause of this adverse event is that it was due to patient condition and not related to bw product.This adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event is that it is not related with the bw product.The physician considered that the patient might have originally had a weak cardiac conduction system because the patient had a first-degree atrioventricular block before the ablation procedure.The patient outcome of the adverse event is improved.The patient had a pacemaker placed because the patient's own pulse did not return the next morning.The patient did require extended hospitalization because of the adverse event because of pacemaker implantation.Other relevant history includes 1st-degree atrioventricular block a smartable generator was used during this case.
Additional Manufacturer Narrative
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.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrioventricular nodal reentry tachycardia (avnrt) ablation procedure with a navistar¿ electrophysiology catheter and the patient suffered heart block requiring surgical intervention and prolonged hospitalization.During an avnrt procedure, during slow pathway ablation, av block occurred.Spontaneous pulse was developed only in the a wave.His electrical signal was not visible.Av block was observed in sinus immediately after the junction which was not fast continued.Therefore, ablation was immediately stopped, but autologous pulse did not return.Temporary pacemaker implantation was performed, and the patient was moved out of the room.It was decided to check whether the patient developed an autologous pulse in the ward.The patient was monitored until the next morning.The patient¿s own pulse did not return, and a pacemaker was implanted.The doctor commented that the patient¿s impulse conducting system may have been weak due to the patient's pre-operative history of atrioventricular block (type 1).The physician¿s opinion on the cause of this adverse event is that it was due to patient condition and not related to bw product.Device investigation details: the device investigation has been completed which included performing a manufacturing record evaluation (mre).Since no device has been received for analysis, no product evaluation can be performed, and the customer complaint cannot be confirmed.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation performed for the finished device 30705355m, and no internal actions related to the complaint was found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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¿ ELECTROPHYSIOLOGY CATHETER A
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 15048051
• Report Number: 2029046-2022-01649
• Device Sequence Number: 17521626
• Product Code: DRF
• UDI-Device Identifier: 10846835000597
• UDI-Public: 10846835000597
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2023

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: 01/04/2025
• Device Model Number: NS7TCDL174HS
• Device Catalogue Number: NS7TCDL174HS
• Device Lot Number: 30705355M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2022
• 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: SMARTABLATE GENERATOR KIT-WW
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 49 KG