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

Catalog Number	BN7TCFJ8L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	09/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Since no lot number was provided, no device history record (dhr) review could be performed.Concomitant product: achieve spiral (model# unknown, lot# unknown).Manufacture reference no: (b)(4).
Event or Problem Description
It was reported that a patient underwent a cryoablation procedure for atrial fibrillation with an ez steer¿ nav ds bi-directional electrophysiology catheter and suffered a cardiac tamponade requiring pericardiocentesis.Post-procedure, the patient was noticed to have a pericardial effusion and low blood pressure.Cardiac tamponade was confirmed and pericardiocentesis was performed to remove an unspecified amount of fluid form the pericardium.It is unknown if extended hospitalization was required as a result of the adverse event.The patient was reported to be in stable condition and was discharged from hospital.The physician did not attribute the causality of the adverse event to a biosense webster inc.(bwi) product.There were no error messages reported on any bwi equipment during the procedure.It is unknown if transseptal puncture was performed.The patient received anticoagulant (unspecified) during the procedure.The activated clotting time (act) was >600 seconds during the cryo portion.Multiple attempts have been made to gain clarification on this event with no response.However, no further information has been made available.The ez steer¿ nav ds bi-directional electrophysiology catheter was used for calibration matrix and completion of a cavotricuspid ishmus (cti) line in the right atrium for atrial flutter.
Additional Manufacturer Narrative
It was reported that a patient underwent a cryoablation procedure for atrial fibrillation with an ez steer¿ nav ds bi-directional electrophysiology catheter and suffered a cardiac tamponade requiring pericardiocentesis.On 11/19/2018, additional information was received indicating that the physician¿s opinion regarding the cause of the adverse event is that it was patient condition-related.The patient outcome was recovered.Transseptal puncture was performed with a brk-1 transseptal needle.Concomitant products: brk-1 transseptal needle (model# unknown, lot# unknown).Manufacture reference no: (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: 8003418
• Report Number: 2029046-2018-02207
• Device Sequence Number: 16250321
• Product Code: OAD
• UDI-Device Identifier: 10846835003048
• UDI-Public: 10846835003048
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2018

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 Catalogue Number: BN7TCFJ8L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 12/12/2018
• 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