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

Catalog Number	601604710
Medical Device Problem Code	Connection Problem (2900)
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
It was reported that "control syringe backing off of the manifold during procedures." due to this, "threw away the manifold, replaced it with another one off the shelf ".
Additional Manufacturer Narrative
It was reported that "control syringe backing off of the manifold during procedures." due to this, "threw away the manifold, replaced it with another one off the shelf ".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.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 (b)(4) on (b)(6) 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
Updated h6, h7.
Additional Manufacturer Narrative
It was reported that "this is a serious safety concern for air leak with these coming lose or off during transeptal procedures in the left atrium".

• Brand Name: MEDLINE
• Common Device Name: MTS,LEFT HEART,KIT,VIDANT MED CTR
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 10 glens falls technical park; glens falls NY 12801 3864
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24526802
• Report Number: 3015910259-2026-00074
• Device Sequence Number: 18252621
• 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: Company Representative
• Initial Reporter Occupation: Nurse
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2026

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: 601604710
• Device Lot Number: 0000183286
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 03/16/2026; Not provided
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 03/24/2026; 04/02/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown