MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D132701, PMA # P030031/S053

Lot Number	UNKNOWN
Medical Device Problem Codes	High Sensing Threshold (2574); Impedance Problem (2950)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Cardiac Tamponade (2226); Not Applicable (3189)
Date of Event	04/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.As such the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.(b)(4).
Event or Problem Description
It was reported that a (b)(6) male patient underwent an ablation procedure for ventricular tachycardia with a thermocool® smart touch® sf bi-directional navigation catheter and suffered a cardiac arrest (requiring defibrillation) and a cardiac tamponade (requiring pericardiocentesis and surgical intervention).Pre-procedure, the patient was admitted to the facility post-myocardial infarction and ventricular tachycardia.Post-admission, the patient was intubated.At an unspecified point, the patient went into ventricular tachycardia and ventricular fibrillation and received greater than 30 defibrillator shocks (icd and external).During the procedure, there were 2 acute increases in impedance and high force readings on the force graph (but not on the dashboard).After approximately 60 minutes of ablation, the patient became hypotensive and a pericardial effusion was detected.Pericardiocentesis yielded an unspecified volume of fluid.Patient required an open chest surgical intervention to repair a tear in the cardiac tissue.There is no information regarding extended hospitalization or patient outcome.Physician indicated that the adverse event was secondary to catheter manipulation and the number of shocks delivered.It was noted that the smarttouch catheter was not at fault.Since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Common Device Name: SIMILAR DEVICE D132701, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 7485271
• Report Number: 2029046-2018-01513
• Device Sequence Number: 1456510
• Product Code: LPB
• UDI-Device Identifier: 10846835010169
• UDI-Public: 10846835010169
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P030031/S053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/09/2018

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 Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 65 YR