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

Model Number	D132704
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	02/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an unknown female patient underwent ischemic ventricular tachycardia (isvt) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.It was reported that the patient suffered a pericardial effusion.Near the end of the case the intracardiac echocardiography (ice) catheter was used to confirm a pericardial effusion.A pericardiocentesis was performed extracting about 1100cc of fluid.A drain was placed for overnight.Patient was stable.Procedure was aborted.They were using an average of 40 watts in the left ventricle.The physician thought the quad catheter in the right ventricle might have caused a perforation.No further intervention was expected.The patient outcome of the adverse event is improved.The patient did require extended hospitalization because of the adverse event as drain was placed overnight.Generator information: sn: (b)(4) and ref m490003.There was no evidence of steam pop.The event occurred post ablation.An irrigated catheter was used in the event, the flow setting was 17 cc.Correct catheter settings were selected on the generator.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.The force visualization features used were dashboard, vector, and visitag.The visitag module was used, the parameters for stability used were 3 mm, 3 grams, 25% 3 seconds.The additional filter used with the visitag was respiration adjustment.The color option used prospectively was impedance drop.Conservatively, this event will be considered reportable as the medical team confirmed that this event was noted post ablation therefore, we cannot exclude bwi devices even though they mention that the physician thought the quad catheter in the right ventricle might have caused a perforation.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.
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On 5-jul-2022, the product investigation was completed as the complaint device was not returned.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the 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).

• 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 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13754360
• Report Number: 2029046-2022-00507
• Device Sequence Number: 4839673
• Product Code: LPB
• UDI-Device Identifier: 10846835009194
• UDI-Public: 10846835009194
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2022

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 Model Number: D132704
• Device Catalogue Number: D132704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Supplement Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: BSX QUAD WOVEN.; CARTO 3 SYSTEM.; SMARTABLATE GENERATOR.; UNSPECIFIED PUMP.; VISITAG MODULE.
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Female