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 Code	Cardiac Tamponade (2226)
Date of Event	06/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number 30772097m and no internal action 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 an ez steer¿ thermocool® nav bi-directional catheter.The patient suffered cardiac tamponade requiring a pericardiocentesis.After doing a pulmonary vein isolation (pvi) procedure and after the isolation of all 4 veins, the physician retracted the sheath from left atrium to right atrium to check the cti line.At that point, he saw a drastic pressure change and he realized that there was a cardiac tamponade (likely due to transseptal puncture not done exactly at the fossa ovalis site).He stopped immediately the procedure and was able to stop the bleeding, taking out all the blood in the pericardium.The procedure was successfully completed.Additional information was received on the event.The physician¿s opinion on the cause of this adverse event is that it was due to transseptal puncture during the procedure.This was a pvi case, and a perforation of the heart chamber occurred due to transseptal puncture.The patient outcome of the adverse event from the last update provided is fully recovered with no residual effects.A transseptal puncture was performed using an abbott brk tsp needle.There was no evidence of steam pop.An irrigated catheter was used in the event, the flow setting was 2ml/min (low flow), 20ml/min (high flow).No error messages were observed on biosense webster equipment during the procedure.This complaint will be conservatively reported as ablation was performed prior to the event.

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 14950992
• Report Number: 2029046-2022-01547
• Device Sequence Number: 6905480
• Product Code: OAD
• UDI-Device Identifier: 10846835003338
• UDI-Public: 10846835003338
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 07/07/2022

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: 04/07/2025
• Device Model Number: BNI75TCDFH
• Device Catalogue Number: BNI75TCDFH
• Device Lot Number: 30772097M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2022
• 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-ABBOTT BRK TSP NEEDLE; SMARTABLATE GENERATOR KIT-WW; UNKNOWN BRAND SHEATH
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Male