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

Model Number	D-1313-05-S
Health Effect - Clinical Codes	Death (1802); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132)
Date of Event	11/17/2016
Type of Reportable Event	Death
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: carto 3 system (model# m-4800-01 serial# (b)(4)).Stockert 70 system (model# unknown serial# unknown).Coolflow pump (model# unknown serial# unknown).Soundstar eco catheter (model# m-5723-17 serial# unknown).Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent an idiopathic ventricular tachycardia procedure with a thermocool® sf nav bi-directional catheter and went into ventricular fibrillation and deceased.After ablation, the patient went into ventricular fibrillation and could not be converted into sinus rhythm.Cardiopulmonary resuscitation was performed and external and internal defibrillation was done.In addition, an impella left ventricular assist device was inserted with no resolution.The patient then deceased.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 (b)(6) 2016.The patient was male.The event occurred during use of biosense webster inc.(bwi) products.The physician¿s opinion on the cause of the death is preexisting condition.It is noted bwi products did not cause the death.Manufacturer's ref.No: (b)(4).
Additional Manufacturer Narrative
The bwi failure analysis lab received the device for evaluation on 12/21/2016.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 idiopathic ventricular tachycardia procedure with a thermocool® sf nav bi-directional catheter and went into ventricular fibrillation and deceased.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.After that, 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 the 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.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 death remains unknown.

• 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: 6151953
• Report Number: 9673241-2016-00855
• Device Sequence Number: 416303
• Product Code: LPB
• UDI-Device Identifier: 10846835003208
• UDI-Public: (01)10846835003208(11)160304(17)190228(10)17425373L
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup,Followup
• Report Date (Section B): 11/17/2016

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: 02/28/2019
• Device Model Number: D-1313-05-S
• Device Catalogue Number: BNI35DFCT
• Device Lot Number: 17425373L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/17/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 12/07/2016
• Supplement Report FDA Received Date: 12/14/2016; 01/09/2017; 01/17/2017
• 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: Death