MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NAMIC MEDLINE; MTS,LEFT HEART,KIT,VIDANT MED CTR

Catalog Number	601604710
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility on 2/9/2026, the control syringe was reported to back off of the manifold during use.
Additional Manufacturer Narrative
According to the facility on 2/9/2026, the control syringe was reported to back off of the manifold during use.The facility reported this as a safety concern for potential air leak during transseptal procedures.The manifold was discarded and replaced with another unit from the same lot, and the same issue was reported to occur.No injuries were reported.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Update to b5, h6, h7, and h9.After further investigation, it has been determined that according to the facility on 2/9/2026, the control syringe was reported to back off of the manifold during use.The facility reported this as a safety concern for potential air leak during transseptal procedures on the left atrium.The investigation involved an analysis of production records and the device was not returned.The investigation identified a manufacturing process problem and the cause has been traced to a manufacturing deficiency related to recall r-26-025.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility on 2/9/2026, the control syringe was reported to back off of the manifold during use.The facility reported this as a safety concern for potential air leak during transseptal procedures on the left atrium.

• Brand Name: MEDLINE
• Common Device Name: MTS,LEFT HEART,KIT,VIDANT MED CTR
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NAMIC; 10 glen falls technical park; technical park drive; glen falls NY 12801 3864
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093-2753
• MDR Report Key: 24525108
• Report Number: 3015910259-2026-00075
• Device Sequence Number: 13201374
• Product Code: OEZ
• UDI-Device Identifier: 10193489071795
• UDI-Public: 10193489071795
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

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
• Device Catalogue Number: 601604710
• Device Lot Number: 0000183286
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: R-26-025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown