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

Model Number	BN7TCDF8L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	06/10/2020
Type of Reportable Event	Serious Injury
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 was performed for the finished device 30297227m 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 ref.# (b)(4).
Event or Problem Description
It was reported that a male patient in his 60s, weighing (b)(6) lbs.With history of previous pulmonary vein isolation (pvi) ablation procedure, underwent an atrial fibrillation (afib) ablation procedure with an ez steer¿ nav ds bi-directional electrophysiology catheter and suffered cardiac tamponade requiring pericardiocentesis.During the ablation phase of the procedure, while maneuvering the ez steer¿ nav ds bi-directional electrophysiology catheter in the left atrium (la), the ez steer¿ nav ds bi-directional electrophysiology catheter suddenly came back into the right atrium (ra) and a drop-in the patient¿s blood pressure was noticed by anesthesiologist.Cardiac tamponade was confirmed via an acunav ultrasound catheter.The location of the effusion is unknown.Pericardiocentesis was performed to remove 350ml of fluid from the pericardial space, and the drainage was left in place.The patient recovered fully in procedure room after pericardial drainage and was admitted for overnight observation in the intensive care unit (icu).It is unknown if extended hospitalization was required.Patient's outcome is fully recovered.Physician is unsure of reason for effusion.Transseptal puncture was performed with an abbott brk transeptal needle.There was no evidence of steam pop during the ablation.No bwi product malfunctions nor error messages were reported.The parameters for stability used with the visitag module were of 2mm for 5 seconds.No other visitag filter used.No other color options used.Max wattage used was 60watts.The total ablation lesions were about 15-20 lesions.

• Brand Name: EZ STEER NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 10256038
• Report Number: 2029046-2020-00840
• Device Sequence Number: 11413974
• Product Code: OAD
• UDI-Device Identifier: 10846835003000
• UDI-Public: 10846835003000
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P010068/S6
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/10/2020

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: 10/01/2022
• Device Model Number: BN7TCDF8L
• Device Catalogue Number: BN7TCDF8L
• Device Lot Number: 30297227M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Weight: 81