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

Catalog Number	BD710DF282RTS
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	10/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 31099798m number, and no internal action related to the complaint was found during the review.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.Or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 patient underwent a cardiac ablation procedure using webster ® cs catheter with ez steer¿ technology.The patient experienced pericardial effusion that resulted in procedure cancellation.During the procedure, the medical team noted a pericardial effusion during a standard check.The pericardial effusion was confirmed by ice (intracardiac echocardiography).The medical intervention included providing protamine to the patient and the patient continued to be monitored.The procedure was canceled.The patient was reported to be in stable condition.The cause of the pericardial effusion could not be confirmed but they were having trouble inserting the cs catheter earlier in the procedure.The catheter had an issue falling out and ¿keeping it in¿.The physician could not confirm if this caused the pericardial effusion or if it was caused by something else prior to the procedure.Physician's opinion on the cause of the adverse event was the procedure.The patient had fully recovered.Patient did not require extended hospitalization.No transseptal puncture was performed.No ablation was performed prior to noting pericardial effusion.No evidence of steam pop.This occurred during the mapping phase.The fellow and attending both has issues getting cs (coronary sinus) catheter in place.When the catheter was believed to be secured, it'd worked its way out of place several times.
Additional Manufacturer Narrative
**udi related data quality updates only** correction to the initial mdr, incomplete udi was provided.Section d4.Primary udi number has been updated with full udi (b)(4).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).

• 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
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18052155
• Report Number: 2029046-2023-02504
• Device Sequence Number: 17631005
• Product Code: DRF
• UDI-Device Identifier: 10846835002416
• UDI-Public: (01)10846835002416(11)230707(17)260706(10)31099798M
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2023

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: 07/06/2026
• Device Catalogue Number: BD710DF282RTS
• Device Lot Number: 31099798M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2023
• 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: OCTARAY CATHETER; SMARTABLATE GENERATOR; SOUNDSTAR CATHETER
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female