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

Catalog Number	D131803
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802); Cardiac Tamponade (2226)
Date of Event	03/27/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.A manufacturing record evaluation was performed for the finished device 30108871l number, and no internal action was found during the review.Manufacturer¿s ref # (b)(4).
Event or Problem Description
It was reported that a female patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® sf nav uni-directional catheter and suffered cardiac tamponade (requiring pericardiocentesis) asystole (requiring reanimation treatment) and death.During the procedure in ablation phase when repositioning the thermocool® sf nav uni-directional catheter in the right ventricle outflow tract (rvot), cardiac perforation occurred.Patient¿s blood pressure was not sable; therefore, pericardiocentesis was performed to remove an unspecified amount of fluid from the pericardium.Pericardiocentesis could not stabilize patient¿s blood pressure.The patient went into asystole, reanimation phase was performed for over 90 minutes without success and the patient was transported.The ablation procedure was delayed to the adverse event and not completed.Subsequently the expired.Physician¿s opinion regarding the cause of the death is that it was caused by the perforation and cardiac tamponade.Transseptal puncture was performed with a brk-1 transseptal needle.There was no evidence of steam pop during the ablation.The catheter irrigation was set in low flow at 2 ml/min and at high flow between 8-15 ml/min.No error messages were observed on any bwi equipment during the case.The parameters for stability used with the visitag module were 3 mm/3 seconds.No additional filters were used with the visitag module.The color option used prospectively was time.
Additional Manufacturer Narrative
During an internal review on (b)(6) 2019, it was noted that "manufacturer address street line 1¿ on the 3500a initial report needed correction.It was initially submitted as ¿31 technology drive¿.The correct address is ¿33 technology drive¿.Therefore, ¿manufacturer address street line 1¿ has been re-populated.Manufacturer's ref # (b)(4).

• 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: 8521339
• Report Number: 2029046-2019-03000
• Device Sequence Number: 2675753
• Product Code: LPB
• UDI-Device Identifier: 10846835009279
• UDI-Public: 10846835009279
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P030031/S034
• 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,Followup
• Report Date (Section B): 03/27/2019

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: 08/26/2021
• Device Catalogue Number: D131803
• Device Lot Number: 30108871L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 04/29/2019
• 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: Death; Required Intervention