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

Catalog 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	10/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was discarded.Therefore, no product failure analysis can be conducted and device malfunction cannot be confirmed.A manufacturing record evaluation was performed for the finished device and no internal actions were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).
Event or Problem Description
It was reported that a male patient underwent a paroxysmal atrial fibrillation ablation procedure with a webster ® cs catheter with ez steer® thechnology and auto id and suffered cardiac tamponade requiring pericardiocentesis.After the transseptal puncture, prior to ablation, the patient had a drop-in blood pressure.A small effusion was then confirmed using intracardiac echocardiogram.Neosynephrine and fluid was administered, and the patient's pressure stabilized.The patient was then awakened from anesthesia.No further intervention was performed, and patient was transferred to the intensive care unit.The physician believes the effusion was a result of difficult coronary sinus (cs) cannulation, due to abnormal patient anatomy.The physician spent a considerable amount of time trying to place in the cs.Physician reported that the transseptal seemed straight forward.The physician did not indicate any biosense webster inc.Products contributing to the event.A baseline echo was not performed.Therefore, it is unknown if the effusion was present pre-procedure.No ablation was performed.

• 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: 9342712
• Report Number: 2029046-2019-03894
• Device Sequence Number: 14133664
• Product Code: DRF
• UDI-Device Identifier: 10846835002409
• UDI-Public: 10846835002409
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/24/2019

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 Expiration Date: 08/01/2022
• Device Catalogue Number: BD710DF282CT
• Device Lot Number: 30269296M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 11/19/2019
• 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: Life Threatening; Required Intervention
• Patient Age: 60 YR