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	04/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a female patient (age in 40s) underwent an unknown ablation procedure with a navistar¿ electrophysiology catheter.The patient suffered complete heart block.After procedure, complete heart block occurred, and a pacemaker was scheduled to be inserted.The patient was affected.The physician's judgment on health injury is that it is serious.The causality with product is unknown.There were no abnormalities observed before or during use of the product.The plastic part of the pin box slot was broken.This occurred when preparing the procedure.Procedure was continued as-is.Version information - v7.1.80.33.The procedure was successfully completed without patient consequence.Additionally, a signal noise occurred only in lab on ablation catheter 1-2.Carto 3 electrical signal was displayed clearly.This occurred when the ablation catheter was inserted into the cardiac cavity.They completed the procedure by inserting the map 1 -2 in the ¿icout¿ into another lab-pin box; the noise continued.The case continued with a noise filter in lab.After that, the ablation catheter electrical signal in the laboratory naturally became clear.There was no reproducibility in post-case verification.Additional information was received on 10-may-2022.Heart block was discovered post use of biosense webster products.Planned pacemaker implantation.The patient outcome of the adverse event was improved.The generator used in the case was a smartablate.Additional information was received on 13-may-2022.The physician reported that the block disappeared, and the pacemaker was removed from the patient.Additional information received in a (b)(4) received on 23-may-2022.The physician¿s opinion on the cause of this adverse event was that it was procedure related.The physician commented that an abnormal voltage index might have missed because it was difficult to cooperate with ¿me¿ since it was the facility where procedures were performed occasionally and the ¿me¿ was low experienced.Although pacemaker implantation was initially planned, the patient eventually returned to normal rhythm and no pacemaker was implanted.The patient outcome of the adverse event was fully recovered (no residual effects).The patient does not have relevant tests/laboratory data.The patient does not have other relevant history.Since the event (heart block) 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
An analysis of the product could not be performed since a physical sample was not received for evaluation.A device history record evaluation was performed for the finished device 30691759m number, and no internal action related to the complaint was found during the review.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 14504688
• Report Number: 2029046-2022-01132
• Device Sequence Number: 5151645
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

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: 12/07/2024
• Device Model Number: NS7TCFL174HS
• Device Catalogue Number: NS7TCFL174HS
• Device Lot Number: 30691759M
• 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: 04/28/2022
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2021
• 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: UNK_CARTO 3; UNK_SMARTABLATE GENERATOR
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female