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-1292-05-S

Device Problem Unintended Movement (3026)

Patient Problems Stroke/CVA (1770); Death (1802); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)

Event Date 05/13/2015

Event Type  Death  

Event Description

It was reported that a patient, (b)(6) year old, male, underwent a persistent atrial fibrillation procedure with an ez steer thermocool nav 4mm catheter and suffered a cardiac tamponade, cerebrovascular accident and deceased.The patient¿s medical history is unknown.The tamponade was due to imperfect maneuver of the catheter from user/operator during the procedure.There was no device problem; the ablation catheter was in a good condition.Additional information was received on the event.A transseptal puncture was performed with a st.Jude medical brk needle.The tamponade occurred during the ablation phase.The overall time for ablation at the site of injury was 15-20 seconds.Tapping the bleeding was done because of the tamponade and then the patient was intubated.The patient¿s condition worsened.The blood pressure dropped and the patient had a stroke after the procedure.Additional treatment was provided by the hospital.Extended hospitalization was required due to the adverse event.Eventually, the patient expired on (b)(6) 2015.The physician¿s opinion regarding the cause of this adverse event is that this is procedure related.Settings during the event include: 30 watts for the anterior side of left atrium and 25 watts on the posterior side / flow setting during ablation was 30 ml /min / merit medical prelude 8f sheath was used.The power was titrated during ablation.There were no error messages observed on biosense webster equipment during the procedure.Anticoagulation was given and maintained every 1 hour.

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.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 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.(b)(4).

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 06/11/15.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).

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).It was reported that a patient, (b)(6), male, underwent a persistent atrial fibrillation procedure with an ez steer thermocool nav 4mm catheter and suffered a cardiac tamponade, cerebrovascular accident and deceased.Per the event, the catheter was tested for electrical performance, temperature response and stockert compatibility and it was found within specifications.Furthermore, an irrigation test was performed and the catheter passed, no occlusion was observed.A deflection test was performed and the catheter failed.Afterwards, an x-ray of the catheter was taken and it was noticed that the t bar slid down from its place.However the failure is not related with the complaint.An internal corrective action has been opened to address deflection issues for t bar sliding down and folded.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 and death 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 3259 9; MX 32599
• Manufacturer Contact: shahe garabedian ; 9098397362
• MDR Report Key: 4837931
• MDR Text Key: 5933580
• Report Number: 9673241-2015-00359
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: D-1292-05-S
• Device Catalogue Number: BNI75TCDFH
• Device Lot Number: 16021357M
• Other Device ID Number: (01)10846835003338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2014
• 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): Death; Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 85