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

Model Number	D132704
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	09/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (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¿ bi-directional navigation catheter (stsf) and suffered cardiac tamponade (ct) requiring pericardiocentesis.During the procedure, after the left atrium ablations were done, and before the cavotricuspid isthmus (cti) line was burned, a pericardial effusion was noticed.The patient's blood pressure dropped slightly.When sweeping the intracardiac echocardiogram (ice) by to get a view of the cti to go to the right side, the pericardial effusion was confirmed.The medical intervention provided was a pericardiocentesis and an unknown amount of fluid were removed.The patient was reported to be in stable condition.The physician believed that the patient¿s atrium was just very unhealthy and extensive ablation necessary in the left atrium was the cause.The patient¿s condition was reported to have improved.At the time of reporting, the patient was mostly recovered.About 260cc's were removed during the pericardiocentesis and then a slow drain was left in, which was able to be removed the following morning.The patient did not require extended hospitalization.Transseptal puncture was performed with a baylis nrg transeptal needle.Prior to noting the ct, ablation was performed.There was no evidence of a steam pop.It is unknown at what phase (transseptal phase, mapping phase or ablation phase) the event occurred.Standard stsf flow settings were 15cc's when burning at greater than 30 watts.The correct catheter settings were selected on the generator.The pump was switching from low to high flow during ablation.There were no error messages observed on the biosense webster equipment during the procedure.Force visualization features used were: dashboard, vector and visitags were used but not colored based on force.The visitag module was used with parameters for stability set at: 2mm, 3s, 25% of 3g, size 3.No additional filter was used with the visitag and color options used prospectively was tag index.

• Brand Name: THERMOCOOL SMART TOUCH BI-DIRECTIONAL NAVIGATION CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12637296
• Report Number: 2029046-2021-01760
• Device Sequence Number: 11675257
• Product Code: LPB
• UDI-Device Identifier: 10846835009194
• UDI-Public: 10846835009194
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/14/2021

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 Model Number: D132704
• Device Catalogue Number: D132704
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 10/14/2021
• 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