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

Catalog Number	D132702
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	02/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.A manufacturing record evaluation was performed for the finished device and no non-conformances was found during the review.(b)(4).
Event or Problem Description
It was reported that a male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool smart touch bidirectional (stsf) catheter and suffered cardiac tamponade requiring pericardiocentesis.During ablation phase near the end of the procedure, the patient¿s blood pressure dropped slightly.Cardiac tamponade was confirmed by intracardiac echo (ice).Pericardiocentesis was performed to remove an unspecified amount of fluid from the pericardium.Pericardial drain was left in place.The patient was reported to be in stable condition after pericardial drainage.Extended hospitalization was required as a result of the event.Patient¿s outcome was fully recovered.Physician¿s causality opinion is unknown.No error messages were observed on any bwi equipment during the procedure.Transseptal puncture was performed with an unknown transseptal needle.There was no evidence of steam pop during the ablation.The irrigation was set within standard settings for stsf.The force visualization features used included graph, dashboard, vector and visitag.The parameters for stability used with the visitag module were 4mm/4seconds respiratory gated.No additional filter was used with the visitag.The color option used prospectively was force.

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8418878
• Report Number: 2029046-2019-02801
• Device Sequence Number: 13831965
• Product Code: LPB
• UDI-Device Identifier: 10846835009170
• UDI-Public: 10846835009170
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S053
• 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): 02/18/2019

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: 04/10/2019
• Device Catalogue Number: D132702
• Device Lot Number: 30039477M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 03/13/2019
• 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: Hospitalization; Life Threatening; Required Intervention