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

Model Number	D-1313-04-S
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	05/18/2016
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: carto 3 system, model #: m-4800-01, serial #: (b)(4).Smartablate generator, model #: m-4900-07, serial #: (b)(4).Smartablate pump, model #: m-4900-08, serial #: (b)(4).
Event or Problem Description
It was reported that a male patient underwent an ablation procedure for a right atrial flutter with an ez steer thermocool sf navigational catheter and suffered a cardiac tamponade requiring a pericardiocentesis.During the ablation phase, at the middle stage of the procedure, a steam pop was noticed by the physician.The physician did not believe there was any injury at this time.The cardiac tamponade was noticed after the procedure.A pericardiocentesis was performed which yielded 300cc of fluid.The patient was stabilized and transferred to the intensive care unit for observation.There is no information regarding extended hospitalization.The patient fully recovered with no residual effects.There were no factors cited that may have contributed to the adverse event.The physician's opinion regarding the cause of the adverse event is that it was procedure-related.The transseptal puncture was performed with an unknown needle.There is no information regarding the sheath used.The generator was set to power control mode at 40 watts and was not titrated.The temperature cut-off was set to 80 celsius.The impedance cut-off was set at 250 ohms.There is no information regarding overall ablation time, last ablation cycle time at the site of injury, or length of the ablation cycle when the steam pop was observed.The irrigated catheter flow was set on standard thermocool sf settings.No error messages were observed on the biosense webster inc.Equipment during the procedure.There is no information regarding anticoagulation used during the procedure.Since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.
Additional Manufacturer Narrative
(b)(4).Manufacturer's ref.No: (b)(4).It was reported that a male patient underwent an ablation procedure for a right atrial flutter with an ez steer thermocool sf navigational catheter.During the ablation phase, at the middle stage of the procedure, a steam pop was noticed by the physician.The physician did not believe there was any injury at this time.The cardiac tamponade was noticed after the procedure.A pericardiocentesis was performed which yielded 300cc of fluid.The patient was stabilized and transferred to the intensive care unit for observation.There is no information regarding extended hospitalization.The patient fully recovered with no residual effects.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 sensor of the catheter was tested on carto system.The catheter was recognized by the carto 3 system, no error messages were displayed and the catheter was properly visualized.The eeprom data demonstrates the catheter was properly calibrated during manufacturing.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 remains unknown.The instructions for use (ifu) states that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.

• Brand Name: THERMOCOOL® SF NAV BI-DIRECTIONAL 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: 5728277
• Report Number: 9673241-2016-00372
• Device Sequence Number: 13594245
• Product Code: LPB
• UDI-Device Identifier: 10846835003260
• UDI-Public: (01)10846835003260(11)160227(17)190131(10)17424892L
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S025
• 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): 05/18/2016

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: 01/31/2019
• Device Model Number: D-1313-04-S
• Device Catalogue Number: BNI35FJCT
• Device Lot Number: 17424892L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2016
• Supplement Report FDA Received Date: 07/06/2016
• 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