MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; LEFT HEART,KIT,-,MARION

Catalog Number	VASC1073A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Fluid getting behind the plunger when aspirated.
Additional Manufacturer Narrative
It was reported that "fluid is getting behind the plunger when we draw back.We can actually see blood behind the plunger in the syringes when we aspirate a sheath.We have had a couple with that issue today".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
Updated made to: e1.

• Common Device Name: LEFT HEART,KIT,-,MARION
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield; northfield, IL 60093-2753
• MDR Report Key: 21874063
• Report Number: 3015910259-2025-00034
• Device Sequence Number: 18108976
• Product Code: OES
• UDI-Device Identifier: 10889942781881
• UDI-Public: 10889942781881
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: VASC1073A
• Device Lot Number: 24LBB122
• 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: 03/24/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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