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	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	03/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old male patient underwent an atrial flutter (afl) ablation procedure with ez steer¿ nav ds bi-directional electrophysiology catheter and suffered cardiac tamponade requiring pericardiocentesis.During radiofrequency ablation of the cavotricuspid isthmus (cti), the patient became hypotensive and pericardial effusion was diagnosed via transesophageal echocardiogram (tee).Pericardiocentesis was performed to drain the fluid from the pericardial space.Patient was reported in stable condition and had fully recovered.Prolonged hospitalization was not required.Physician¿s opinion regarding the cause of the event is that it was procedure related.No bwi product malfunction was reported.Transseptal puncture was done with a baylis needle.There was no evidence of steam pop during the ablation.Standard flow settings were used.The correct catheter settings were selected on the generator.The pump was switching from low to high flow during the ablation.The force visualization features used included graph, dashboard, vector and visitag.The parameters for stability used with the visitag module were 3 mm 3 sec 25% over 3 3 mm.Time was used as coloring option.No additional filter was used.
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on (b)(6) 2021.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).During an internal review on (b)(6) 2021, noted a correction to the 3500a initial as the physician information was omitted in error.Therefore, updated e.Initial reporter section accordingly.
Additional Manufacturer Narrative
It was reported that a 79.-year-old male patient underwent an atrial flutter (afl) ablation procedure with ez steer¿ nav ds bi-directional electrophysiology catheter and suffered cardiac tamponade requiring pericardiocentesis.Patient was reported in stable condition and had fully recovered.Prolonged hospitalization was not required.The device evaluation was completed on 5/19/2021.The catheter was returned to biosense webster for evaluation.Bwi conducted a visual inspection, c3 system, electrical, generator, and deflection test of the returned catheter.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the ez steer nav ds catheter.C3 system, electrical, and generator test were performed, in accordance with bwi procedures and no issues were observed.In addition, the catheter was deflecting correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of bwi¿s quality process all catheters are manufactured, inspected, and released to approved specifications.The root cause of the adverse event remains unknown.The instructions for use states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.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 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: 11713740
• Report Number: 2029046-2021-00654
• Device Sequence Number: 14394267
• Product Code: OAD
• UDI-Device Identifier: 10846835003000
• UDI-Public: 10846835003000
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P010068/S6
• 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,Followup
• Report Date (Section B): 03/26/2021

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 Expiration Date: 02/04/2024
• Device Model Number: BN7TCDF8L
• Device Catalogue Number: BN7TCDF8L
• Device Lot Number: 30491095M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 04/22/2021; 05/19/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 04/29/2021; 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NON BWI- BAYLIS TRANSSEPTAL NEEDLE; UNKNOWN BRAND GENERATOR; UNKNOWN BRAND PUMP; UNK_CARTO 3
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention