MAUDE Adverse Event Report: Biosense Webster Inc VARIPULSE¿ Bi-Directional Catheter; Percutaneous Cardiac Abl Cath for Treatmt of AFib w Irreversible Electroporation

Catalog Number	D141201
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure and after ablation with a varipulse¿ bi-directional catheter, they noticed the smartablate irrigation tubing set was disconnected at the catheter end (no damage noticed).There were no errors displayed.The pump was flowing, just not into the catheter, and there was no pool of fluid found.They also cardioverted, and there was no injury to patient.Additional information indicated that it is not known exactly how it became disconnected.Mid-way through the case, the physician noticed that it got disconnected and the issue was resolved.It is suspected that it came off during the cardioversion (planned), however, it remains unknown.
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.Manufacturer's reference number: (b)(4).

• Brand Name: VARIPULSE¿ Bi-Directional Catheter
• Common Device Name: Percutaneous Cardiac Abl Cath for Treatmt of AFib w Irreversible Electroporation
• 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: katie seppa ; 31 technology dr; irvine, CA 92618 ; +1(513)337-8052
• MDR Report Key: 50850135
• Report Number: 3013300026-2026-03088
• Device Sequence Number: 9953805
• Product Code: QZI
• UDI-Device Identifier: 10846835025460
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P240006
• 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
• Report Date (Section B): 09/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: D141201
• Device Lot Number: 31908662L
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2026
• 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
• Patient Sex: Unknown