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

Catalog Number	NR7TCSIY
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	11/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2023-02734 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter) (2) mfr # 2029046-2023-02735 for product code nr7tcsiy (navistar® rmt thermocool® electrophysiology catheter).
Event or Problem Description
It was reported a patient underwent an idiopathic ventricular tachycardia (idvt) procedure ablation procedure which included the use of a thermocool® smart touch® sf bi-directional navigation catheter and a navistar® rmt thermocool® electrophysiology catheter and the patient suffered cardiac tamponade requiring per pericardiocentesis, a sternotomy and prolonged hospitalization.After ablation, they were preparing to go left sided and patient became hypotensive.Using ultrasound they saw a pericardial effusion.A pericardiocentesis was performed, an unknown amount of fluid was removed.Then a sternotomy was performed patient was stable when they left the lab to go to the intensive care unit (icu) and hospitalized for a week.Discharged with full recovery.Physician's opinion the cause was ablating on the free wall of the right ventricle where tissue is thinner.No steam pop.Correct settings on devices and no error messages on the equipment.
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) on 19-dec-2023, it was noticed the incorrect manufacture ref # was reported in the supplemental (follow-up) mdr # 1 as "(b)(4)".The correct manufacture ref # is (b)(4).
Additional Manufacturer Narrative
It was reported a patient underwent an idiopathic ventricular tachycardia (idvt) procedure ablation procedure which included the use of a thermocool® smart touch® sf bi-directional navigation catheter and a navistar® rmt thermocool® electrophysiology catheter and the patient suffered cardiac tamponade requiring per pericardiocentesis, a sternotomy and prolonged hospitalization.After ablation, they were preparing to go left sided and patient became hypotensive.Using ultrasound they saw a pericardial effusion.A pericardiocentesis was performed, an unknown amount of fluid was removed.Then a sternotomy was performed patient was stable when they left the lab to go to the intensive care unit (icu) and hospitalized for a week.Discharged with full recovery.Device investigation details: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.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® RMT THERMOCOOL® 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: 18187589
• Report Number: 2029046-2023-02735
• Device Sequence Number: 7322208
• Product Code: OAD
• UDI-Device Identifier: 10846835008500
• UDI-Public: 10846835008500
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P030031
• 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,Followup
• Report Date (Section B): 12/19/2023

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 Catalogue Number: NR7TCSIY
• 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: Not provided
• Supplement Date Received by Manufacturer: 12/19/2023; 12/19/2023
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 12/18/2023; 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 7FR DECAN,11P,F,2.4MMLE,282MM,; CARTO 3 SYSTEM.; PENTARAY NAV ECO 7FR, F, 2-6-2.; SMARTABLATE GENERATOR KIT-US.; THMCL SMTCH SF BID, TC, D-F.; UNKNOWN PUMP.
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 98 KG