MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SF NAV; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	BNI35DFCT
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	08/10/2017
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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.The device history record (dhr) for the lot number 17637072l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent a cavotricuspid isthmus (cti) ablation procedure for right atrial flutter with an ez steer thermocool sf nav catheter and suffered a cardiac tamponade requiring pericardiocentesis.During the procedure, while ablating the cti line, a steam pop occurred.Patient became hypotensive and an effusion was confirmed via transthoracic echocardiography.Pericardiocentesis yielded approximately 280 ml of blood and fluid.Patient was reported to be in stable condition.Patient remained hospitalized for observation.It was noted that the physician does not believe a biosense webster, inc.Product was responsible for the injury.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.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 SF NAV
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 6843880
• Report Number: 9673241-2017-01037
• Device Sequence Number: 16308575
• Product Code: LPB
• UDI-Device Identifier: 10846835003208
• UDI-Public: (01)10846835003208(11)170202(17)200131(10)17637072L
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S025
• 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): 08/10/2017

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 Expiration Date: 01/31/2020
• Device Model Number: BNI35DFCT
• Device Catalogue Number: BNI35DFCT
• Device Lot Number: 17637072L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2017
• Initial Report FDA Received Date: 09/05/2017
• 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: Hospitalization; Life Threatening; Required Intervention