MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR DS ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	NS7TCF8L174HS
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	08/10/2021
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 (b)(6) male patient (b)(6) underwent an atrioventricular nodal re-entrant tachycardia (avnrt) with a navistar" ds electrophysiology catheter.The patient suffered cardiac tamponade requiring pericardiocentesis and prolonged hospitalization.After the avnrt case was completed, a pericardial effusion was noticed.The pericardial effusion was discovered when the patients blood pressure dropped.The pericardial effusion was confirmed by echo.Medical intervention provided was a pericardiocentesis and 425 cc of fluid was removed.The patient was reported to be in stable condition.This adverse event was discovered post use of biosense webster products.The physicians opinion on the cause of this adverse event was that he was unsure.The physician thinks it could have been the his or coronary sinus catheter placement in this patient, so patient condition.Pericardiocentesis to drain 425cc.Patient outcome of the adverse event was that the patient fully recovered (no residual effects).The patient required extended hospitalization because of the adverse event of 2 additional days for stabilization and monitoring.Relevant tests/laboratory data: hemoglobin 10.5; hematocrit 32.1; platelets 149, other relevant history: plavix last taken the day before ((b)(6) 2021).Smartablate generator was used.A transseptal puncture was not performed.Prior to noting the cardiac tamponade, the ablation was performed.There was no evidence of steam pop.The event occurred maybe while placing catheters initially.The correct catheter settings were selected on the generator.No error messages observed on biosense webster equipment during the procedure.

• Brand Name: NAVISTAR DS ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12411956
• Report Number: 2029046-2021-01474
• Device Sequence Number: 4687372
• Product Code: OAD
• UDI-Device Identifier: 10846835000603
• UDI-Public: 10846835000603
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P010068
• 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): 08/10/2021

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: NS7TCF8L174HS
• Device Catalogue Number: NS7TCF8L174HS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SMARTABLATE GENERATOR KIT-US; WEBSTER CS EZ STEER CATHETER NON-AUTO-ID CATHETER
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 77