MAUDE Adverse Event Report: Biosense Webster Inc WEBSTER; Catheter, Electrode Recording

Catalog Number	D6FR252RT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	07/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an ablation procedure with a webster catheter and experienced a cardiac tamponade which required pericardiocentesis.After procedure, patient was alert and oriented during groin access closure, but just after, the patient dropped their blood pressure to 50/20 and became non-responsive.Doctor used an ultrasound machine and checked with a probe on the patient¿s chest for a pericardial effusion.The patient did have one, therefore, the doctor performed a pericardiocentesis on the patient and a total of 400cc came out.Patient was stabilized, woke up and blood pressure was 152/73 on no medications.Extended hospitalization was required as the patient spent the night in the intensive care unit.Patient fully recovered.Blood pressure stabilized and she became alert and orientated again.She just has pain in her chest where the drain is.Doctor believes biosense quad catheter perforated the right ventricle.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.
Additional Manufacturer Narrative
D4: udi: as the lot number provided for the device involved in the event was not recognized in the system, the full udi is currently not available.Multiple attempts have been made to obtain clarification on the lot number.However, no further information has been made available.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.Manufacturer's reference number: (b)(4).

• Brand Name: WEBSTER
• Common Device Name: Catheter, Electrode Recording
• Manufacturer (Section D): Biosense Webster Inc; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): Foxconn Baja California; parque industrial el lago; tijuana
• Manufacturer Contact: katie seppa ; 31 technology dr; irvine, CA 92618 ; +1(513)337-8052
• MDR Report Key: 50077585
• Report Number: 3013300026-2026-02444
• Device Sequence Number: 10252853
• Product Code: DRF
• UDI-Device Identifier: 10846835004502
• UDI-Public: 10846835004502
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K892265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2026

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 Catalogue Number: D6FR252RT
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/31/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2026
• Supplement Date Received by Manufacturer: 07/31/2026; 08/28/2026
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 08/25/2026; 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 220 LB