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); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	10/27/2016
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 medical product: lasso nav variable eco (model#: d-1343-01-s lot #: 17497532l).(b)(4).
Event or Problem Description
It was reported that a male patient, over (b)(6), underwent an atrial fibrillation procedure with a thermocool® smarttouch® uni-directional navigation catheter and suffered a cardiac tamponade, which required pericardiocentesis.While mapping, sometime between transseptal and ablation, a pericardial effusion was noticed as the patient's blood pressure dropped.No ablations were performed.The pericardial effusion was confirmed by echocardiogram.A pericardiocentesis was performed and 1500cc of fluid was removed.Post procedure the patient was stable and transferred to the intensive care unit for observation (icu).The patient was monitored in the icu overnight and required additional days in the telemetry unit post-icu.The patient¿s condition has since improved.The physician was unsure exactly when the effusion occurred.However, believes it happened during the transseptal puncture.There was no product malfunction.A transseptal puncture was done with a baylis needle.A st jude medical sl1 sheath was used during the procedure.The patient received anticoagulant during the procedure, however the activated clotting time is unknown.Irrigation flow was set to 2ml/min during mapping phase.There are no known patient factors that might have contributed to the event.There were no reported error messages on biosense webster inc equipment during the procedure.
Additional Manufacturer Narrative
(b)(4).It was reported that a male patient, over 60 years old, underwent an atrial fibrillation procedure with a thermocool® smarttouch® uni-directional navigation catheter and suffered a cardiac tamponade, which required 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 was evaluated for eeprom, and the functionality of the sensors of the catheter were tested on carto 3 system.The catheter was recognized by carto 3 system, no error messages were displayed and the catheter was properly visualized.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.The force features was evaluated and passed.Finally, 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 cardiac tamponade remains unknown.The instructions for use states 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: 6119519
• Report Number: 9673241-2016-00812
• Device Sequence Number: 10816062
• Product Code: LPB
• UDI-Device Identifier: 10846835009019
• UDI-Public: (01)10846835009019(11)160518(17)170430(10)17469789M
• Combination Product (Y/N): N
• 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): 10/27/2016

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: 04/30/2017
• Device Model Number: D-1336-03-S
• Device Catalogue Number: D133603
• Device Lot Number: 17469789M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2016
• Supplement Report FDA Received Date: 01/06/2017
• 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