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-1292-05-S

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 08/11/2015

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.Full udi # information unavailable since the lot number is unknown.(b)(4).

Event Description

It was reported that a patient, (b)(6) male, underwent a pulmonary vein isolation and cavo tricuspid isthmus ablation procedure with an ez steer¿ thermocool® nav bi-directional catheter and suffered a cardiac tamponade, which required pericardiocentesis.During the ablation a steam pop occurred with 40 watts of energy.A few hours after the procedure, a pericardial effusion was discovered, possibly due to the steam pop.A puncture was done in which approximately 500ml of bloody fluid was removed.The patient was reported to be in stable condition at the time the complaint was reported.The patient did require hospitalization for 7 days.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

Additional information was received on the event on september 22, 2015.A transseptal puncture was performed with a brk-1 needle.The patient did receive anticoagulation which was maintained at 300-350s during the procedure.The event occurred during the ablation phase during cavotricuspid isthmus ablation.The patient has since fully recovered with no residual effects.The power was not titrated during ablation.Settings during the event include: power control /power setting 40 watts / temperature cut-off 45 degrees celsius/ irrigation flow setting 30 ml/min / st.Jude medical lamp 45 sheath was used.There were no error messages observed on biosense webster equipment during the procedure.The physician¿s opinion regarding the cause of this adverse event is that this is most likely procedure related as ablation was performed with high energy, however in this kind of procedure high energy is necessary.(b)(4).

• 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: 5098356
• MDR Text Key: 26594248
• Report Number: 2029046-2015-00227
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-1292-05-S
• Device Catalogue Number: BNI75TCDFH
• Device Lot Number: UNKNOWN_D-1292-05-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2015
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 69 YR