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

Model Number	D131503
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); No Code Available (3191)
Date of Event	12/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device with lot number 30264860l, and no internal actions related to the reported complaint condition were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a male patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® sf nav uni-directional catheter and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.During the ablation phase the physician heard or felt a steam pop, the patient became hypotensive and cardiac tamponade was confirmed.Pericardiocentesis was performed to remove an unspecified amount of fluid from the pericardial space.The patient was then transported to the operating room (or) for surgical intervention.Extended hospitalization was required as a result of the adverse event.Patient condition improved and was reported in stable condition.The physician did not attribute the causality of the adverse event to the biosense webster, inc.Product and suggested it was procedure-related.Transseptal puncture was not performed.The color option used prospectively was time.The steam pop was assessed as not mdr-reportable.Steam pop is not considered to be a device malfunction.Steam pop is an expected physiological phenomenon.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 UNI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9619829
• Report Number: 2029046-2020-00133
• Device Sequence Number: 14184918
• Product Code: LPB
• UDI-Device Identifier: 10846835009293
• UDI-Public: 10846835009293
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/26/2019

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: 08/04/2022
• Device Model Number: D131503
• Device Catalogue Number: D131503
• Device Lot Number: 30264860L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/26/2019
• Initial Report FDA Received Date: 01/23/2020
• 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