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	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	09/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent a premature ventricular contractions (pvc) cardiac ablation procedure utilizing a webster ® cs catheter with ez steer® thechnology and auto id and the patient experienced cardiac tamponade and required medical interventions.It was reported pericardial effusion was noticed once the catheters were pulled out of the body and confirmed on a transthoracic echo.The patient's blood pressure dropped.The effusion was treated by pericardiocentesis with 2500cc¿s fluid withdrawn.Patient transported to the operating room (or) for open heart surgery because the bleeding would not stop and subsequently required an extended hospital stay.Physician¿s opinion is the adverse event was caused by the procedure.When the patient went into surgery, they discovered that the perforation was in the coronary sinus.The caller believed that ¿the patient must have had a hole and when they pulled the catheter, it must have opened up that hole and it must have started to bleed." the caller reported that the physician did not believe the catheter itself caused the issue.Patient fully recovered and has been discharged post op surgical care.No transseptal puncture performed, ablation had been performed and no evidence of steam pop.Correct settings selected on devices, and no error messages on equipment during procedure.
Additional Manufacturer Narrative
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 ref.# (b)(4).
Additional Manufacturer Narrative
On 15-nov-2023, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Additional Manufacturer Narrative
It was reported a patient underwent a premature ventricular contractions (pvc) cardiac ablation procedure utilizing a webster ® cs catheter with ez steer® thechnology and auto id and the patient experienced cardiac tamponade and required medical interventions.It was reported pericardial effusion was noticed once the catheters were pulled out of the body and confirmed on a transthoracic echo.The patient's blood pressure dropped.The effusion was treated by pericardiocentesis with 2500cc¿s fluid withdrawn.Patient transported to the operating room (or) for open heart surgery because the bleeding would not stop and subsequently required an extended hospital stay.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.Physician¿s opinion is the adverse event was caused by the procedure.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
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® 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18000409
• Report Number: 2029046-2023-02421
• Device Sequence Number: 15354401
• Product Code: DRF
• UDI-Device Identifier: 10846835002409
• UDI-Public: (01)10846835002409(11)230413(17)260412(10)31040531M
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/18/2023

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: 04/12/2026
• Device Catalogue Number: BD710DF282CT
• Device Lot Number: 31040531M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2023
• Supplement Date Received by Manufacturer: 11/15/2023; 11/28/2023; 07/11/2024
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 11/16/2023; 12/18/2023; 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2023
• 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: BI DIR 7FR DEF CS,D-F,12 PIN; SMARTABLATE GENERATOR KIT-US; THMCL SMTCH SF BID, TC, D-F
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male