MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number D-1292-01-S

Device Problem Device Alarm System (1012)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 11/02/2015

Event Type  Injury  

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)), stockert 70 system (model# m-5463-01 serial# (b)(4)), coolflow pump (model# m-5491-02 serial# (b)(4)).(b)(4).

Event Description

It was reported that a female patient underwent an idiopathic ventricular tachycardia procedure with a thermocool smarttouch bi-directional navigation catheter and an ez steer thermocool nav bi-directional catheter, and suffered a cardiac tamponade, which required pericardiocentesis and protamine.The smarttouch catheter was used first and the catheter stopped fully deflecting towards the curve.The catheter was replaced with the ez steer thermocool catheter and the case resumed.A pericardial effusion was noticed as the patient's blood pressure dropped.The pericardial effusion was confirmed by intracardiac echocardiogram.A pericardiocentesis was performed and protamine was administered.Additional information was received on the event.The patient was provided heparin for anticoagulation and normal ranges were observed.No transseptal puncture was performed.Event occurred during ablation phase.It is unknown if the patient required hospitalization due to the event.The last ablation was about 3-4 seconds.Settings during the event include: power control mode and power varied within 30-35 watts / irrigation setting was 30 ml/min.The power was not titrated during ablation and no error messages were observed on biosense webster equipment during the procedure.The physician's opinion regarding the cause of this adverse event is that this may have been caused with the thermocool catheter since force values are not indicated with this type of catheter and because the event occurred after the physician switched from the smarttouch catheter to standard 4mm thermocool catheter.However since both catheters were used prior to the event, this event will be conservatively reported under both ablation catheters used.

Manufacturer Narrative

(b)(4).It was reported that a female patient underwent an idiopathic ventricular tachycardia procedure with an ez steer¿ thermocool® nav bi-directional catheter, and suffered a cardiac tamponade, which required pericardiocentesis and protamine.The returned device was visually inspected upon receipt and it was found in normal conditions.Per the event, an irrigation test was performed and the catheter passed, no occlusion was observed.A deflection test was performed and the catheter passed.The catheter was tested for electrical performance, temperature response and stockert compatibility and it was found within specifications.The catheter was also evaluated for carto 3.The catheter was recognized by carto 3 system, no error messages were displayed and the catheter was properly visualized.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 states that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.

• Brand Name: EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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 ; 9497893837
• MDR Report Key: 5248343
• MDR Text Key: 32100984
• Report Number: 9673241-2015-00864
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• 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
• Report Date: 11/02/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: D-1292-01-S
• Device Catalogue Number: BNI75TCDDH
• Device Lot Number: 16010828M
• Other Device ID Number: SEE H10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2015
• Initial Date FDA Received: 11/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2013
• 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