MAUDE Adverse Event Report: Biosense Webster Inc nGEN Pump; Cardiac ablation percutaneous catheter

Catalog Number	D139702
Medical Device Problem Codes	Mechanical Jam (2983); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction

• Brand Name: nGEN Pump
• Common Device Name: Cardiac ablation percutaneous catheter
• Manufacturer (Section D): Biosense Webster Inc; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): Biosense Webster, Inc.; 560 cottonwood drive; milpitas CA
• Manufacturer Contact: katie seppa ; 31 technology dr; irvine, CA 92618 ; +1(513)337-8052
• MDR Report Key: 50873877
• Report Number: 3013300026-2026-03132
• Device Sequence Number: 21498119
• Product Code: LPB
• UDI-Device Identifier: 10846835017472
• UDI-Public: 10846835017472
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: D139702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown