MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVI-STAR RMT ELECTROPHYSIOLOGY CATHETER; ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION

Model Number	NR7TCS4Y
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Cardiac Tamponade (2226)
Date of Event	08/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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 complaints that are related to the same incident.Manufacturer's reference number: (b)(4).
Event or Problem Description
Initially this event was assessed as a serious injury under the thermocool® smart touch® sf bi-directional navigation catheter.Additional information was received on 10/1/2020 stating that the 4mm non-irrigated catheter was being used for mapping.Ablation was performed with this catheter for a few seconds only.Since it was confirmed that ablation was performed for a few seconds with the 4 mm catheter, its relationship with the adverse event occurrence cannot be excluded; therefore, this event is also now assessed as a serious injury under the 4mm non-irrigated catheter with the awareness date of (b)(6) 2020.It was reported that a female patient underwent an atrioventricular reentrant tachycardia/wolff-parkinson-white syndrome (avrt/wpw) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a navi-star¿ rmt electrophysiology catheter and suffered cardiac tamponade (requiring pericardiocentesis) and cardiac arrest (requiring cardiopulmonary resuscitation (cpr)).During the procedure, a 4mm non-irrigated catheter was being used for mapping the left atrium.Ablation was done with this catheter for a few seconds only; however, the physician noticed they were not achieving enough contact force, and decided to switch to a thermocool® smart touch® sf bi-directional navigation catheter.No issues were experienced with the 4mm catheter.During the ablation phase with the thermocool® smart touch® sf bi-directional navigation catheter, the physician attempted pacing out of atrial tachycardia but was unsuccessful, so a cardioversion was performed.At this point the patient¿s blood pressure dropped.An echocardiogram using intracardiac echocardiography revealed the effusion.The patient went into cardiac arrest, and cpr was performed.Then, pericardiocentesis was performed to remove 700 cc of fluid from the pericardial space.Protamine was also administered.Patient was reported in stable condition and was moved to the intensive care unit (icu) with the pericardial drain in place.It is unknown if extended hospitalization was required.The physician did not believe that biosense webster inc.Products contributed to the patient event.Visitag and force dashboard were both used, with visitag settings at 1.5 and 3.0 with no force over-time settings.Average force was used as the visitag setting.The pacing leads were through the piu, and it was pacing to pace out of the atrial tachycardia.There wasn¿t any unwanted pacing being delivered.

• Brand Name: NAVI-STAR RMT ELECTROPHYSIOLOGY CATHETER
• Common Device Name: ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 10753301
• Report Number: 2029046-2020-01583
• Device Sequence Number: 16942848
• Product Code: LPB
• UDI-Device Identifier: 10846835008463
• UDI-Public: 10846835008463
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/31/2020

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 Model Number: NR7TCS4Y
• Device Catalogue Number: UNK_NAVISTAR RMT 4MM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM; THMCL SMTCH SF BID, TC, D-F
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 48 YR