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

Catalog Number	BNI75TCFJH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Death (1802)
Date of Event	03/16/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.(b)(4).
Event or Problem Description
It was reported that a (b)(6)-year-old female patient underwent an ablation procedure for inappropriate sinus tachycardia (ist) with anez steer¿ thermocool® nav bi-directional catheter and suffered a heart block av (requiring pacing) and death.During the procedure, sinus node modification/ablation was performed for a total of 1 minute.Patient became hypoxic and bradycardic.It was noted that the bradycardia seemed unrelated to the radiofrequency ablation.Pacing was initiated via the coronary sinus (cs) catheter.Patient continued to deteriorate and an atrioventricular block was observed.Patient was intubated.Pacing was switched from the cs catheter to the right ventricular (rv) catheter.The rv stopped capturing and the patient went into ventricular tachycardia (vt), which progressed to ventricular fibrillation (vf).Cardiopulmonary resuscitation (cpr) was initiated.Pharmacologic support was provided.Resuscitation efforts were unsuccessful and the patient expired.Physician¿s opinion regarding the cause of the adverse event is that it was related to the procedure and/or the patient¿s condition.There were no issues or errors reported on any bwi products or equipment during the procedure.Since the adverse event resulted in the patient¿s death, it is mdr reportable.

• Brand Name: EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7423939
• Report Number: 2029046-2018-01423
• Device Sequence Number: 39269
• Product Code: OAD
• UDI-Device Identifier: 10846835003376
• UDI-Public: 10846835003376
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P030031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: BNI75TCFJH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Life Threatening; Required Intervention; Disability
• Patient Age: 59 YR
• Patient Weight: 91