MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NOGA-STAR¿ CARDIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	120708S
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	01/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional physician information: initial reporter title: dr.Initial reporter first name: (b)(6).Initial reporter last name: (b)(6).Initial reporter email: (b)(6).The bwi product analysis lab received the device for evaluation 20-feb-2023.The 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.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).
Event or Problem Description
It was reported that a patient underwent an electromechanical mapping ablation procedure with a noga-star¿ cardiology catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.It was reported that a pericardial effusion was noted during the case and bedside eco was done to confirm it.They stated that a pericardiocentesis was completed and the initial fluid removal was 350ml.The patient is still suffering from chest discomfort and is still under observation with an output of 5-10ml per hour the bp is 103/62 and hr 103.Procedure: electromechanical mapping and transendocardio injection with stem cells.Hector study.Additionally, physician¿s opinion on the cause of this adverse event is the procedure related.No surgical intervention required.Only pericardiocentesis and medical management was done.Patient has fully recovered (no residual effects).Patient was admitted on (b)(6) 2023 and discharged on (b)(6) 2023.There was no cardiac ablation provided during this procedure.No confirmation that the stay was considered extended.Therefore, assessed as no prolonged hospitalization.
Additional Manufacturer Narrative
It was reported that a patient underwent an electromechanical mapping ablation procedure with a noga-star¿ cardiology catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.The device evaluation was completed on 09-mar-2023.The product was returned to biosense webster (bwi) for evaluation.A visual inspection and an evaluation of all features of the device were performed following bwi procedures.Visual analysis revealed that no damage or anomalies on the device.The magnetic, electrical, and deflecting feats were tested.No malfunctions were observed during the product analysis.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.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.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: NOGA-STAR¿ CARDIOLOGY CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16419024
• Report Number: 2029046-2023-00343
• Device Sequence Number: 17020290
• Product Code: DRF
• UDI-Device Identifier: 10846835002058
• UDI-Public: 10846835002058
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K954390
• 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): 04/05/2023

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: 04/12/2024
• Device Model Number: 120708S
• Device Catalogue Number: 120708S
• Device Lot Number: 30443618M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2021
• 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: DEF 7F,INJ,2P,F,4LE,.5MM,HYP
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 77 KG