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

Catalog Number	BNI35DDH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	09/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was stated that the customer is retaining the device.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a (b)(6) male patient underwent a premature ventricular contraction (pvc) ablation procedure on the left basal posteroseptal region of the left ventricle with a thermocool® sf nav bi-directional catheter and suffered cardiac tamponade requiring pericardiocentesis.Prior to the procedure, the ct scan showed a mild effusion.Thirteen radiofrequency (rf) applications were applied to the pvc origin in the left ventricle (lv).The patient¿s blood pressure dropped at the last rf application.Cardiac tamponade was confirmed by echo.Pericardiocentesis was performed to remove the fluid from the pericardium.Patient was reported to be stable throughout the procedure.The pvc ablation could be completed successfully.Patient is planned to be discharged at the following day as per protocol.There¿s no information regarding physician¿s causality opinion.There were no error messages reported on any biosense webster, inc.Equipment during the procedure.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.
Additional Manufacturer Narrative
Additional information was received on the event on (b)(6) 2018.Patient¿s outcome is fully recovered with no residual effects.Physician believes there was pre-existing effusion which may have further developed post procedure; however, the exact cause of the adverse event is unknown.There were no impedance or temperature rise or any suspicion of steam pop.Manufacturer's ref.No: (b)(4).

• 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: 7993860
• Report Number: 2029046-2018-02195
• Device Sequence Number: 13729465
• Product Code: LPB
• UDI-Device Identifier: 10846835003192
• UDI-Public: 10846835003192
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: P030031/S025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2018

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: BNI35DDH
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 10/14/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 11/05/2018
• 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
• Patient Age: 40 YR