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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); No Code Available (3191)
Date of Event	06/15/2020
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.(b)(4).Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year old female patient underwent atrial fibrillation (afib) ablation with thermocool® smart touch¿ bi-directional navigation catheter and suffered cardiac tamponade requiring surgical intervention.During ablation phase, shortly after transseptal through the atrioseptal defect (asd) a pericardial effusion was noticed as the patient's blood pressure dropped.The pericardial effusion was confirmed by intracardiac echocardiography (ice).Caller reported that the medical intervention provided was a pericardiocentesis and 3 litters of fluid were removed and proceeded with open heart surgery.The patient was reported to be in stable condition.This adverse event was discovered during use of biosense webster products.The opinion of the physician is that the sheath and needle were inserted through atrioseptal defect (asd) and perforated through left atrial appendage (laa).Thus, the cause of the event is patient condition/procedure.Pericardiocentesis was performed followed by open heart surgery to close asd and repair hole.The patient¿s condition is improved and stable.The patients required extended hospitalization for post surgery recovery.Prior to noting the effusion ablation was performed on posterior wall of left pulmonary vein (lpv) and ridge.There was no evidence of steam pop, high force nor high impedance.The caller commented that the event occurred during ablation phase shortly after transseptal through the asd.The irrigation settings were standard for thermocool® smart touch¿ bi-directional navigation catheter.There were no error messages observed on biosense webster equipment during the procedure.All available force visualization modules were used (graph, dashboard, vector and visitag).Visitag settings were 3 mm 3 seconds force over time (fot) 25% 3 grams.Respiration adjustment was used for additional filter with the visitag.Tag index (surpoint) used for color options.Given that ablations were performed, the contribution of the biosense webster device cannot be excluded.Thus this event will be conservatively reported under the thermocool® smart touch¿ bi-directional navigation catheter.

• 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: 10242598
• Report Number: 2029046-2020-00819
• Device Sequence Number: 2853423
• Product Code: LPB
• UDI-Device Identifier: 10846835009194
• UDI-Public: 10846835009194
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/15/2020

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): Initial
• Initial Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 07/07/2020
• 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
• Patient Age: 70 YR