MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	D132704
Medical Device Problem Codes	High Readings (2459); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	02/17/2022
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.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a male patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter.The patient suffered cardiac tamponade requiring a pericardiocentesis.The patient had a cardiac tamponade that was noticed during the mapping phase when there was a drop in the patient's blood pressure.The tamponade was confirmed via an intracardiac echocardiogram.The patient had a pericardiocentesis and 1300ml of fluid were removed.The patient did not require any surgical repair and is stable as of the time of the call and is being kept for observation overnight.The physician thought the tamponade occurred over time throughout the course of the procedure.Additional information was received on the event.The physician¿s opinion on the cause of this adverse event was procedure related.The patient outcome was fully recovered (no residual effects).A transseptal puncture was not performed.Ablation was not performed prior to the cardiac tamponade.There was a high force error messages observed on biosense webster equipment during the procedure.Force visualization used was graph, dashboard & vector.Since the event 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.The high force issue was assessed as not mdr reportable.The issue is highly detectable when occurring.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event was low.

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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 ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13775292
• Report Number: 2029046-2022-00520
• Device Sequence Number: 11177874
• Product Code: LPB
• UDI-Device Identifier: 10846835009194
• UDI-Public: 10846835009194
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: D132704
• Device Catalogue Number: D132704
• 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: 02/17/2022
• Initial Report FDA Received Date: 03/15/2022
• 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: DECANAV CATHETER; UNK_CARTO 3; UNK_SMARTABLATE GENERATOR; UNK_SOUNDSTAR
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Male