MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	BNI75TCDFH
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Ventricular Fibrillation (2130)
Date of Event	12/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a premature ventricular contraction (pvc) ablation procedure with a ez steer¿ thermocool® nav bi-directional catheter.The patient suffered ventricular fibrillation and cardiac arrest requiring chest compressions.It was reported that during ablation, the patient¿s heart rate increased due to the ablation effect, and it broke down and became ventricular fibrillation, but did not occur thereafter.This occurred during ablation.The patient returned to sinus mode by dc.In the same way, vf became 5 times when ablation was present, dc was injected twice, and the remaining 2 times stopped spontaneously with chest compression.The procedure was then successfully completed.The physician commented that in particular, they tended to have reactions to ablation.Additional information was received on the event.It was returned to sinus mode by dc.In the same way, vf became 5 times when ablation was present, dc was injected twice, and the remaining 3 times stopped spontaneously when chest compression.The procedure was then successfully completed.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.
Additional Manufacturer Narrative
Initial reporter phone: (b)(6).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 was performed for the finished device 30658253m number, and no internal actions related to the complaint was found during the review.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
Additional information was received on 14-jan-2022.It was reported that the patient is a 32 year female.The adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event was patient condition related.Intervention provided was for each of the 6 vfs, dc (direct-current (dc) cardioversion-defibrillation) was performed 3 times and chest compression was performed 3 times.Patient outcome of the adverse event was improved.The patient did not require extended hospitalization because of the adverse event.Generator used in the procedure was the smartablate generator.Therefore, section a.Patient information and field d 10.Concomitant medical products and therapy dates were populated.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
Additional information was received on 08-feb-2022, clarifying what it meant by ¿dc and that dc was injected twice¿.For 6 ventricular fibrillations, dc (direct-current (dc) cardioversion-defibrillation) was performed 3 times and chest compression was performed 3 times and each time the patient returned to sinus rhythm.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL 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
• 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: 13201250
• Report Number: 2029046-2022-00042
• Device Sequence Number: 13820121
• Product Code: OAD
• UDI-Device Identifier: 10846835003338
• UDI-Public: 10846835003338
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2022

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 Expiration Date: 10/27/2024
• Device Model Number: BNI75TCDFH
• Device Catalogue Number: BNI75TCDFH
• Device Lot Number: 30658253M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2021
• Supplement Date Received by Manufacturer: 01/14/2022; 02/08/2022
• Initial Report FDA Received Date: 01/09/2022
• Supplement Report FDA Received Date: 02/06/2022; 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• 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: SOUNDSTAR ECO SMS 8F CATHETER.; UNK_SMARTABLATE GENERATOR.
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female