MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Model Number	BD710DF282CT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	01/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a male patient underwent atrial fibrillation ablation with webster ® cs catheter with ez steer® technology and auto id and suffered cardiac tamponade requiring pericardiocentesis.During the atrial fibrillation ablation while in the right superior vein with laser balloon technology, the patient¿s blood pressure dropped.The ultrasound confirmed the patient had a pericardial effusion.The patient had a pericardiocentesis and more than one liter of fluid removed from the patient.The patient remained stable during the procedure.The case was canceled.The webster ® cs catheter with ez steer® technology and auto id was in the body at the time of the adverse event.The patient was hospitalized for observation and has fully recovered.The physician¿s opinion regarding the cause of this adverse event is that it was procedure related.A transseptal puncture was performed with a st.Jude medical sl sheath and a baylis transseptal needle.The event occurred during the ablation phase.No errors messages were observed on the biosense webster, inc.Equipment during the procedure.No irrigated catheter was used.No biosense webster, inc.Ablation catheter was used.The event will be conservatively reported under the webster ® cs catheter with ez steer® technology and auto id since it was in the heart during the event.

• Brand Name: WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID
• Common Device Name: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9724523
• Report Number: 2029046-2020-00262
• Device Sequence Number: 13944371
• Product Code: DRF
• UDI-Device Identifier: 10846835002409
• UDI-Public: 10846835002409
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K090898
• 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): 01/23/2020

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 Model Number: BD710DF282CT
• Device Catalogue Number: BD710DF282CT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 02/19/2020
• 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; Life Threatening; Required Intervention