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

Model Number D-1327-05-S

Device Problem Use of Device Problem (1670)

Patient Problem Cardiac Tamponade (2226)

Event Date 09/19/2016

Event Type  Injury  

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, s/n: (b)(4), smartablate pump, model # m-4900-08, s/n: (b)(4), soundstar eco catheter, model # m-5723-17, s/n: (b)(4), st.Jude sheaths, model and lot numbers unknown.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for idiopathic ventricular tachycardia with a thermocool smarttouch bi-directional navigation catheter and suffered a cardiac tamponade requiring pericardiocentesis.During the mapping phase, a tamponade was confirmed via intracardiac echocardiogram.Pericardiocentesis yielded 60ml.Patient was reported to be in stable condition.Patient did not require extended hospitalization as a result of this adverse event.There were no factors cited that may have contributed to the adverse event.Physician's opinion regarding the cause of the adverse event is that it was related to manipulation of the catheter, which was a reprocessed bwi product, during placement in the right ventricle.However, since the smart touch bidirectional catheter was also in use at the time of injury, we will conservatively report it as well.No transseptal puncture was performed.St.Jude medical sheath was used.Generator settings were not reported, as no ablation had been performed.Irrigated catheter flow setting was 2ml/min.Patient did not receive anticoagulant during the procedure.There is no information regarding spi value.Thermocool smarttouch bi-directional navigation catheter was not in close proximity to another catheter.Thermocool smarttouch bi-directional navigation catheter was zeroed after the initial warm-up phase, post-connection to the carto 3.Carto 3 system did not indicate to re-zero the catheter.There were no error messages on any bwi equipment during the procedure.

Manufacturer Narrative

On (b)(6) 2016, 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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Manufacturer's reference number: (b)(4).It was reported that a patient underwent an ablation procedure for idiopathic ventricular tachycardia with a thermocool smarttouch bi-directional navigation 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 the 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 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 state that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.

• Brand Name: THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6031200
• MDR Text Key: 57557889
• Report Number: 9673241-2016-00695
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: (01)10846835009200(11)160823(17)170731(10)17541310M
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 17541310M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention