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	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	02/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an unknown patient underwent an premature ventricular contraction (pvc) ablation procedure with a webster ® cs catheter with ez steer® thechnology and auto id.The patient suffered cardiac tamponade requiring a pericardiocentesis.After a successful ablation in the left ventricle (lv) summit area, the doctor retracted the cs catheter into the right atrium (ra).The cs catheter was too deep into the coronary sinus to be able to detect ventricular signal on the distal portion of the catheter and a couple of minutes after the doctor retracted the cs catheter in the ra, the patient had a sudden pressure drop.Investigation with an ultrasound probe showed pericardial effusion.The blood was immediately drained, and the blood pressure of the patient returned to stable levels.The doctor thinks that the cs might have created the effusion in the pericardium.The surgery was not delayed due to the reported event.The procedure as successfully completed.No fragments were generated.There were patient consequences as the patient had a pericardial effusion.No other medical intervention was required.The patient condition was reported as "fine".The effusion is resolved.A pericardiocentesis was performed.The patient's stay in hospital was extended as a result of the adverse event.The pericardial effusion has not resulted in any further complications.Generator information: stockert, smartablate, g4c3508.No need for servicing for the generator.A transseptal puncture was not performed they went retro aortic.Prior to noting the effusion ablation was performed in the lv summit area.There was no evidence of steam pop.The event occurred after the ablation phase, when the cs catheter was retracted from the coronary sinus to the ra.Ablation performed with st catheter at standard irrigation rates.Correct catheter settings were selected on the generator.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.No error messages were observed on biosense webster equipment during the procedure.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.
Additional Manufacturer Narrative
Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the 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).

• 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; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13856009
• Report Number: 2029046-2022-00599
• Device Sequence Number: 16494736
• Product Code: DRF
• UDI-Device Identifier: 10846835002409
• UDI-Public: 10846835002409
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/22/2022

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): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SMARTABLATE GENERATOR
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Sex: Unknown