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 Code	Cardiac Tamponade (2226)
Date of Event	09/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The bwi failure analysis lab received the device for evaluation.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.Concomitant products: st.Jude medical brk-1 71cm transseptal needle; st.Jude medical sl1 8.5fr 63cm sheath; carto 3 system.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure for atrial fibrillation with a thermocool smarttouch uni-directional catheter and suffered a cardiac tamponade requiring pericardiocentesis.After the procedure was completed and the catheters were removed, the physician was doing a final review with an intracardiac echocardiogram catheter when a tamponade was observed.Patient was asymptomatic.Pericardiocentesis yielded an unknown amount of fluid.Patient left the lab in stable condition.There is no information regarding extended hospitalization.There were no factors cited that may have contributed to the adverse event.It was noted that the physician did not know at what point during the procedure the injury occurred.Physician did not provide a causality opinion.Transseptal puncture was performed with a st.Jude medical brk-1 71cm transseptal needle.Sheath used was a st.Jude medical sl1 63cm 8.5 french.Generator settings throughout the procedure included: power at 25-30 watts (not titrated) and temperature cut-off at 43 degrees celsius.Generator parameters, overall ablation time, and last ablation time at the site of injury are not known.Irrigated catheter flow was set at 2cc/min during mapping and 17cc/min during ablation at 30 watts or less.Patient received heparin boluses throughout the procedure with activated clotting times maintained in an unknown range.There was no information regarding spi value or catheter proximity.Catheter was zeroed after the initial warm-up phase, post-connection to the carto 3 piu.Carto 3 system did not indicate to re-zero the catheter.There were no error messages reported on any bwi products during the procedure.
Additional Manufacturer Narrative
Manufacturer's reference number: (b)(4).It was reported that a patient underwent an ablation procedure for atrial fibrillation with a thermocool smarttouch uni-directional catheter and suffered a cardiac tamponade requiring pericardiocentesis.The returned device was visually inspected and was found in good condition.Per the event, the catheter was tested for electrical performance, temperature response and generator compatibility, and it was found within specifications.A deflection test was performed, which the catheter passed.The catheter was evaluated for eeprom, and sensor functionality was tested on the carto 3 system.The catheter was recognized by carto 3 system with proper visualization and no error messages.Eeprom data demonstrates that the catheter was properly calibrated during manufacturing.The force feature was evaluated and passed.An irrigation test was performed, which 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 cardiac tamponade 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: 6031211
• Report Number: 9673241-2016-00696
• Device Sequence Number: 1420877
• Product Code: LPB
• UDI-Device Identifier: 10846835009019
• UDI-Public: (01)10846835009019(11)160729(17)170630(10)17519485M
• 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
• Report Date (Section B): 09/20/2016

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: 06/30/2017
• Device Model Number: D-1336-03-S
• Device Catalogue Number: D133603
• Device Lot Number: 17519485M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/14/2016
• Supplement Report FDA Received Date: 11/16/2016
• 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