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	11/17/2021
Type of Reportable Event	Serious Injury
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.The patient suffered cardiac tamponade requiring pericardiocentesis.During the procedure, a pericardial effusion was noticed as the patient's blood pressure dropped.The pericardial effusion was confirmed by intracardiac echocardiography.The medical intervention provided was a pericardiocentesis and 600ml of fluid were removed and they put a drain in.The patient was reported to be in stable condition.The physician stated that the patient already had a bad heart, and his pumping function was really low at around 20 % and had other health issue.This event occurred during the pvi case.The physician¿s opinion on the cause of this adverse event was the patient¿s condition.Fluid drained from the effusion.Patient sent to the intensive care unit (icu) for observation overnight.Patient outcome of the adverse event was fully recovered (no residual effects).It is unknown if he required extended hospitalization.The patient was already scheduled to stay the night in the hospital; however, the patient required icu observation due to this event and that may have extended the hospital stay.A transseptal puncture was performed with a baylis needle.Prior to noting the cardiac tamponade, ablation was performed.There was only evidence of the effusion.They did not hear a steam pop or see an impedance jump.The event occurred during the ablation phase.The correct catheter settings were selected on the generator and the pump was switching from low to high flow during ablation.No error messages were observed on biosense webster equipment during the procedure.Force visualization features: graph, dashboard, vector & visitag with the visitag module parameters for stability: max distance change 2.5 mm, minimum time: 3 seconds, fot: 25% of the time of 3 grams or more with no additional filter used with the visitag.Tag index was used for color options (surpoint).
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).
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.The patient suffered cardiac tamponade requiring pericardiocentesis.During the procedure, a pericardial effusion was noticed as the patient's blood pressure dropped.The pericardial effusion was confirmed by intracardiac echocardiography.The medical intervention provided was a pericardiocentesis and 600ml of fluid were removed and they put a drain in.The patient was reported to be in stable condition.The physician stated that the patient already had a bad heart, and his pumping function was really low at around 20 % and had other health issue.This event occurred during the pvi case.The physician¿s opinion on the cause of this adverse event was the patient¿s condition.Fluid drained from the effusion.Patient sent to the intensive care unit (icu) for observation overnight.Patient outcome of the adverse event was fully recovered (no residual effects).It is unknown if he required extended hospitalization.The patient was already scheduled to stay the night in the hospital; however, the patient required icu observation due to this event and that may have extended the hospital stay.A transseptal puncture was performed with a baylis needle.Prior to noting the cardiac tamponade, ablation was performed.There was only evidence of the effusion.They did not hear a steam pop or see an impedance jump.The event occurred during the ablation phase.The correct catheter settings were selected on the generator and the pump was switching from low to high flow during ablation.No error messages were observed on biosense webster equipment during the procedure.Force visualization features: graph, dashboard, vector & visitag with the visitag module parameters for stability: max distance change 2.5 mm, minimum time: 3 seconds, fot: 25% of the time of 3 grams or more with no additional filter used with the visitag.Tag index was used for color options (surpoint).

• 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
• 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: 12981889
• Report Number: 2029046-2021-02168
• Device Sequence Number: 12176421
• 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): 12/12/2021

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 12/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NON BWI-BAYLIS TRANSEPTAL NEEDLE; UNKNOWN BRAND PUMP; UNK_CARTO 3; UNK_SMARTABLATE GENERATOR
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Male