MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	D-1336-03-S
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Tissue Damage (2104); Cardiac Tamponade (2226); Fluid Discharge (2686); Pericardial Effusion (3271)
Date of Event	06/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.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: st.Jude medical brk-1 needle 71cm, model and lot numbers unknown.Sl1 8.5 french sheath, model and lot numbers unknown.(b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure for atrial fibrillation with a thermocool smarttouch unidirectional catheter and suffered a cardiac tamponade requiring pericardiocentesis.During ablation, an effusion was observed via intracardiac echocardiogram.Ablation continued, as the patient was normotensive.Shortly thereafter, the patient became hypotensive and pericardiocentesis was performed, yielding 600cc.Pericardial fluid was returned to the patient.Anticoagulants were administered.Patient was reported to be in stable condition at the time of complaint report.There is no information regarding extended hospitalization or patient outcome.There were no factors cited that may have contributed to the adverse event.It was noted that the injury may have occurred during transseptal access.Physician did not provide a causality opinion.It was also reported that at the beginning of the procedure, impedance readings were higher than normal.It was noted that the patient had a larger than average body habitus.Indifferent electrode was changed without resolution.Transseptal puncture was performed with a st.Jude medical brk-1 needle 71cm and a st.Jude medical sl1 8.5 french sheath.Generator was set on 20-35 watts, depending upon location during ablation.There is no information regarding generator parameters, overall ablation time, or last ablation cycle time at the time of injury.Irrigated catheter flow was set on 17-30ml/min.There were no error messages reported on any bwi equipment during the procedure.Patient received anticoagulant (heparin) during the procedure with activated clotting times maintained between 300-350 seconds.
Additional Manufacturer Narrative
The bwi failure analysis lab received the device for evaluation on 6/29/2016.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.(b)(4).
Additional Manufacturer Narrative
(b)(4).It was reported that a patient underwent an ablation procedure for atrial fibrillation with a thermocool smarttouch unidirectional catheter and suffered a cardiac tamponade requiring pericardiocentesis.The returned device was visually inspected and it was found in normal conditions.Per the event, the catheter was tested for electrical performance, temperature response and generator test and it was found within specifications.A deflection test was performed and the catheter passed.The catheter functionality of the sensors was tested on carto system.The catheter was recognized by carto 3 system, no error messages were displayed and the catheter was properly visualized.The force feature was evaluated and passed.An irrigation test was performed and the catheter passed; no occlusion was observed.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.The catheter passed all specifications.The root cause of the tamponade and high impedance reported remains unknown.The instructions for use state that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.

• Brand Name: THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• MDR Report Key: 5751981
• Report Number: 9673241-2016-00402
• Device Sequence Number: 23870
• Product Code: LPB
• UDI-Device Identifier: 10846835009019
• UDI-Public: (01)10846835009019(11)160411(17)170331(10)17445824M
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S053
• 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,Followup
• Report Date (Section B): 06/02/2016

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: 03/31/2017
• Device Model Number: D-1336-03-S
• Device Catalogue Number: D133603
• Device Lot Number: 17445824M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/02/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/27/2016
• Supplement Report FDA Received Date: 06/30/2016; 07/25/2016
• 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