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

Catalog Number	BN7TCFJ8L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	01/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 (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.Concomitant medical products: carto 3 system (model# fg540000, serial# (b)(4); duodeca catheter (model# d728260rt, lot# 17754542m).(b)(4).
Event or Problem Description
It was reported that a female patient underwent an ablation procedure for atrial flutter with an ez steer nav ds bi-directional electrophysiology catheter and suffered hypotension requiring computed tomography (ct) and vasopressors.Immediately post-ablation, after successful termination of atrial flutter, the patient became hypotensive.Intracardiac echocardiography (ice) was negative for pericardial effusion.Pulmonary angiography was negative for pulmonary embolism.Abdomen was distended, yet supple.Ct was (b)(6) for retroperitoneal bleeding and pulmonary embolism.Patient was admitted to the intensive care unit (icu) intubated and on vasopressors.Patient required extended (overnight) hospitalization as a result of the adverse event.At the time of complaint update, the patient was being weaned from the ventilator in preparation for extubation.Patient was reported to be in stable condition.Medical history includes a previous surgical repair of an atrial septal defect (asd).Physician¿s opinion regarding the cause of the adverse event is that it was related to a significant decrease in cardiac output secondary to termination of long-term atrial flutter.It was noted that the hemoglobin and hematocrit decreased during the procedure, which may have been related to the 3 liters of volume administered for cardiac output support.
Additional Manufacturer Narrative
The bwi failure analysis lab received the device for evaluation on 02/27/2018.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.Manufacturer's ref.No: (b)(4).
Additional Manufacturer Narrative
It was reported that a female patient underwent an ablation procedure for atrial flutter with an ez steer¿ nav ds bi-directional electrophysiology catheter and suffered hypotension requiring computed tomography (ct) and vasopressors.The returned device was visually inspected and it was found in normal conditions.The catheter was evaluated for carto 3 functionality and it was recognized by the system, no error messages were displayed and the catheter was properly visualized.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.Then, the catheter was tested for electrical performance and stockert compatibility and it was found within specifications.Additionally, a deflection test was performed and the catheter passed the test.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 adverse event remains unknown.The instructions for use states that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.Manufacturer's ref.No: (b)(4).

• Brand Name: EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY 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: 7292411
• Report Number: 2029046-2018-01250
• Device Sequence Number: 1237475
• Product Code: OAD
• UDI-Device Identifier: 10846835003048
• UDI-Public: 10846835003048
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P010068/S6
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2018

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 Expiration Date: 11/15/2020
• Device Catalogue Number: BN7TCFJ8L
• Device Lot Number: 17760061M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 01/31/2018; 01/31/2018
• Initial Report FDA Received Date: 02/23/2018
• Supplement Report FDA Received Date: 03/06/2018; 04/05/2018
• 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: Hospitalization