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

Model Number	D134802
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	11/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that female patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered cardiac tamponade requiring monitoring.It was reported that the patient suffered a pericardial effusion during the procedure.The reporter stated that "the physician stated that during the procedure there was resistance when advancing the lasso and acunav catheter.The lasso catheter was used for mapping for about 5-10 minutes.The physician noticed weird anatomy, so they advanced the ablation catheter to map.The patient's blood pressure dropped.The acunav catheter was used to perform an intracardiac echo and the physician confirmed the presence of an effusion.A transesophageal echocardiogram (tee) was performed, and a small effusion was confirmed.The ablation catheter was advanced, and the physician noted unusual geometry, no ablation was performed, and all of the catheters were removed at this point.The physician gave protamine and closed.The physician used tee to continue monitoring and confirmed the effusion was not growing.The patient went to the intensive care unit (icu).After the procedure, the physician mentioned that they might have been mapping extracardiac.The patient is hemodynamically stable at this time.The effusion was discovered/noticed by intracardiac echocardiography (ice).The patient was admitted to the intensive care unit.There is a suspected perforation, and it was confirmed using acunav.No pericardiocentesis was performed.The procedure was abandoned.There was no evidence of any effusion present before the procedure.This adverse event was discovered post use of bwi products.The physician¿s opinion on the cause of this adverse event is that it was procedure related.The outcome of the adverse event is unknown at this time.It is unknown at this time if the patient required extended hospitalization because of the adverse event.Force visualization features used included graph, dashboard and vector.Additional information was later received indicating the reporter was unaware of the medical intervention; the patient was transferred to icu.The patient outcome of the adverse event is fully recovered.Patient date of birth: (b)(6).A smartablate generator was used during procedure.A transseptal puncture was performed with a baylis versacross needle.Prior to noting the cardiac tamponade ablation had not been performed, as such, there was no evident of steam pop.The event occurred during the mapping phase.An irrigated catheter was used in the event, the flow settings were low flow of 2 ml/s, no ablation was performed in this case.Correct catheter settings were selected on the smartablate generator.The pump was not switching from ¿low¿ to ¿high¿ flow as no ablation was performed.No error messages were observed on biosense webster equipment during the procedure.
Additional Manufacturer Narrative
Device investigation details: the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A 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 ref.# (b)(4).
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) on 14-dec-2021, it was noticed that incorrect product information was reported in the section "d10.Concomitant medical products and therapy dates" of the 3500a initial medwatch report.The reported unk_lasso and unk_acunav should have been reported as sterilmed rpo lasso and stryker acunav.These descriptions have been updated in that field.

• Brand Name: THERMOCOOL® SMART TOUCH® SF 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 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12958395
• Report Number: 2029046-2021-02131
• Device Sequence Number: 13891014
• Product Code: LPB
• UDI-Device Identifier: 10846835010152
• UDI-Public: 10846835010152
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030031
• 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,Followup
• Report Date (Section B): 12/28/2021

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: D134802
• Device Catalogue Number: D134802
• 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: 11/11/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 12/29/2021
• 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: BAYLIS VERSACROSS; CARTO 3 SYSTEM; SMARTABLATE GENERATOR KIT-US; STERILMED RPO LASSO; STRYKER ACUNAV; UNK_ACUNAV; UNK_LASSO
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 76 YR
• Patient Sex: Female