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

Model Number	BD710DF282RTS
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	08/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device investigation details: since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30595028m number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# : (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old-male patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a webster ® cs catheter with ez steer¿ technology and the patient suffered cardiac tamponade requiring pericardiocentesis, surgical intervention and prolonged hospitalization.During an ep study using carto sound; during use of biosense webster products, the patient suffered a pericardial effusion.It was discovered when the anesthesiologist stated that the patient was not perfusing.The soundstar intracardiac echo catheter was used to visualize and diagnose the effusion.A pericardiocentesis was performed but was insufficient to stabilize the patient.The patient was sent to the operating room (or) for surgical intervention.The patient's status was unknown at the time of the call.The physician did not indicate that bwi products contributed to the patient event.The physician opinion on the cause of the adverse event was that the non-bwi right ventricular catheter likely caused the issue as the rv catheter perforated the rv.The patient¿s outcome of the adverse event was reported as improved.The patient required extended hospitalization because of the adverse event for monitoring.Transseptal puncture was not performed.No ablation was performed.Event occurred during ep study.No ablation or irrigated catheter was used and no error messages were observed on biosense webster equipment.This event is being conservatively being reported against the bwi catheter that was in use when the adverse event occurred.It was also reported that the carto 3 system workstation crashed pre-procedure, prior to any catheter placement.The study was able to be continued successfully.The case was an ep study, they were only using carto for cartosound module to see the ultrasound image.The caller stated that the software crash occurred prior to catheter insertion, before the case started, and did not contribute to patient event.This issue is not mdr reportable since the potential risk that it could cause or contribute to a death or serious deterioration in state of health is remote.

• Brand Name: WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY
• Common Device Name: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12449628
• Report Number: 2029046-2021-01510
• Device Sequence Number: 17074291
• Product Code: DRF
• UDI-Device Identifier: 10846835002416
• UDI-Public: 10846835002416
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K090898
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/16/2021

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: 06/30/2024
• Device Model Number: BD710DF282RTS
• Device Catalogue Number: BD710DF282RTS
• Device Lot Number: 30595028M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 09/09/2021
• 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
• Patient Age: 64 YR