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

Model Number D-1292-04-S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/14/2015

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Since no lot number was provided, no device history record (dhr) review could be performed.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)).Due to the august 2015 fda maintenance where the 3500a codes were updated, the 3500a codes (b)(4).

Event Description

It was reported that a male patient underwent an ischemic ventricular tachycardia (vt) procedure with an ez steer thermocool nav bi-directional catheter and suffered a cardiac tamponade, which required pericardiocentesis.A cardiac tamponade was noticed as the patient's blood pressure dropped.The cardiac tamponade was confirmed by intracardiac echocardiogram (ice).A pericardiocentesis was performed and 1.4 liters of fluid was removed.Additional information was received on an event.A transseptal puncture was performed with a st.Jude medical brk needle.The patient received heparin drips and boluses to achieve target anticoagulation of 300-350 seconds.The event occurred during the mapping phase.Ablations were performed and all ablation cycles were 60 seconds or less.At end of the procedure and intervention, ice showed no more fluid in pericardial space.The patient stayed intubated following the vt procedure and was kept overnight for observation.The next afternoon, the patient was extubated and stable but remained in the hospital for observation and to perform a follow up echocardiogram to rule out any additional bleeding.The patient has improved and is expected to fully recover.Settings during the procedure include: power control mode / power settings between 35 and 50 watts / temperature cut-off 43 degrees / irrigation flow setting 30cc/min during ablation and 2 cc/min while mapping / st jude medical agilis deflectable sheath "small" curve 8.5f sheath was used.The power was adjusted during ablation, but for signal reduction not with the purpose of reaching a target temperature.There were no error messages observed on biosense webster equipment during the procedure.This physician's opinion on the cause of the event is possibly patient condition and procedure.The patient had ventricular tachycardia, thinning/scarring of some ventricular tissue as shown on an mri report.The patient also had not discontinued plavix.

• 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 (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: joaquin kurz ; 9497893837
• MDR Report Key: 5208274
• MDR Text Key: 30698769
• Report Number: 2029046-2015-00255
• 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
• Report Date: 10/14/2015

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 Model Number: D-1292-04-S
• Device Catalogue Number: BNI75TCFJH
• Device Lot Number: UNKNOWN_D-1292-04-S
• Other Device ID Number: SEE H10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/14/2015
• Initial Date FDA Received: 11/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Life Threatening; Required Intervention