MAUDE Adverse Event Report: LAKE REGION MEDICAL STREAMER ES, J, 195-014

Model Number	363725
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Event or Problem Description
Streamer es-j tears off inside the lead when trying to remove it from the sentus lead (!) (after successful positioning of the lead in a suitable target vein) action taken (what has been done?): the entire lead has to be removed again and was replaced by a new combination (lead + ptca).
Event or Problem Description
Streamer es-j tears off inside the lead when trying to remove it from the sentus lead (after successful positioning of the lead in a suitable target vein) action taken (what has been done?): the entire lead has to be removed again and was replaced by a new combination (lead + ptca).
Additional Manufacturer Narrative
Complaint investigation completed as part of this report.

• Brand Name: STREAMER ES, J, 195-014
• Common Device Name: STREAMER ES, J, 195-014
• Manufacturer (Section D): LAKE REGION MEDICAL; parkmore west business park; galway, H91 C K22; EI H91 CK22
• Manufacturer (Section G): LAKE REGION MEDICAL; lake region medical; galway, H91 C K22; EI H91 CK22
• Manufacturer Contact: barbara krason ; lake region medical; galway, H91 C-K22 ; EI H91 CK22
• MDR Report Key: 24376598
• Report Number: 3006010712-2026-00005
• Device Sequence Number: 4874993
• Product Code: DQX
• UDI-Device Identifier: 04035479126292
• UDI-Public: (01)04035479126292(17)280229(10)8846780
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K083094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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 Model Number: 363725
• Device Catalogue Number: 363725 REV 16
• Device Lot Number: 8846780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2024
• 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