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

Catalog Number	BD710FJ282RTS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Cardiac Tamponade (2226)
Date of Event	07/08/2019
Type of Reportable Event	Death
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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturing record evaluation (mre) review cannot be conducted because no lot number was provided by the customer.Manufacturer's reference # (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure on which a webster ® cs catheter with ez steer¿ technology was used and suffered cardiac tamponade (requiring pericardiocentesis) and death.Upon procedure completion before the catheters were removed, there was no evidence of pericardial effusion, this was confirmed by ultrasound.4 hours post-procedure while the patient was in the recovery room, there was a drop-in blood pressure.Cardiac tamponade was confirmed, and pericardiocentesis was performed to remove an unspecified amount of fluid from the pericardial space.Ultrasound confirmed bleeding had stopped.The patient was stable overnight; however, expired the next day ((b)(6) 2019).The physician could not confirm for sure that the death was related to the procedure, cardiac tamponade or other comorbidities.It was confirmed that no biosense webster, inc.Representative was present for the case.There¿s no information that a therapeutic biosense webster, inc.Catheter was used during the procedure.No biosense webster, inc.Product malfunctions were reported.Multiple attempts have been made to gain clarification on this event with no response.Should any new information be obtained it will be assessed and processed accordingly.

• Brand Name: WEBSTER ® CS CATHETER WITH EZ STEER¿ THECHNOLOGY
• 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: 8903891
• Report Number: 2029046-2019-03555
• Device Sequence Number: 16695856
• Product Code: DRF
• UDI-Device Identifier: 10846835002430
• UDI-Public: 10846835002430
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K090898
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2019

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: BD710FJ282RTS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 08/16/2019
• 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; Required Intervention