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

Model Number NS7TCF8L174HS

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 08/10/2021

Event Type  Injury  

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 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
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12411956
• MDR Text Key: 269518451
• Report Number: 2029046-2021-01474
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835000603
• UDI-Public: 10846835000603
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: NS7TCF8L174HS
• Device Catalogue Number: NS7TCF8L174HS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SMARTABLATE GENERATOR KIT-US; WEBSTER CS EZ STEER CATHETER NON-AUTO-ID CATHETER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 77