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

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 06/14/2022

Event Type  Injury  

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 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
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14950992
• MDR Text Key: 295476792
• Report Number: 2029046-2022-01547
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835003338
• UDI-Public: 10846835003338
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: BNI75TCDFH
• Device Catalogue Number: BNI75TCDFH
• Device Lot Number: 30772097M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/14/2022
• Initial Date FDA Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2022
• 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: NON BWI-ABBOTT BRK TSP NEEDLE; SMARTABLATE GENERATOR KIT-WW; UNKNOWN BRAND SHEATH
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Male