MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	BNI35BBH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	04/20/2018
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.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Concomitant products: cook medical transseptal needle (model# g02364, lot# unknown), agilis 8 french 71 cm sheath.(model # unknown, lot # unknown) , lasso® nav eco catheter (model #d134901, lot# 17744237l), webster¿ electrophysiology catheter (model# d-1079-230-s, lot# unknown), carto® 3 system (model #m-4800-01, serial (b)(4)), stockert generator (model # 39d76x, serial (b)(4).
Event or Problem Description
It was reported that a (b)(6) male patient underwent an ablation procedure for atrial fibrillation with a thermocool® sf nav bi-directional catheter and suffered a cardiac tamponade requiring pericardiocentesis.Left atrial geometry was performed.After approximately 5 minutes of ablation, a pericardial effusion was detected.Pericardiocentesis yielded an unspecified volume of fluid.Hemostasis was achieved.Patient was reported to be in stable condition.Patient required 1 additional day of hospitalization for monitoring.There were no patient factors cited that may have contributed to the adverse event.Physician¿s opinion regarding the cause of the adverse event is that it was related to procedure or patient condition.It is unknown at what point during the procedure the injury occurred.There were no issues or errors reported on any bwi products or equipment during the procedure.Transseptal puncture was performed with a cook medical transseptal needle and an agilis 8 french 71 cm sheath.There is no information regarding generator parameters, generator settings, power titration, overall ablation time at the site of injury, last ablation cycle time at the site of injury, or irrigated catheter flow setting.Patient received anticoagulant during the procedure with activated clotting time (act) maintained between 300-350 seconds.There were no issues or errors reported on any bwi products or equipment during the procedure.

• Brand Name: THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7509246
• Report Number: 2029046-2018-01542
• Device Sequence Number: 1529238
• Product Code: LPB
• UDI-Device Identifier: 10846835003130
• UDI-Public: 10846835003130
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P030031/S025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2018

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 Expiration Date: 06/30/2020
• Device Catalogue Number: BNI35BBH
• Device Lot Number: 17702679L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 05/11/2018
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 65