MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC THRUPORT SYSTEMS INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE; CLAMP, VASCULAR

Model Number	ICF100
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Intraclude intra-aortic occlusion device would not flush cardioplegia.Manufacturer response for intra aortic occlusion device, edwards (per site reporter).Incident reported to vendor by hospital's quality team.

• Brand Name: THRUPORT SYSTEMS INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 22059387
• Report Number: 22059387
• Device Sequence Number: 7634318
• Product Code: DXC
• UDI-Device Identifier: 00690103190007
• UDI-Public: (01)00690103190007(17)260703(11)240703(10)BSLC7316
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/13/2025
• Report Date (Section F): 05/12/2025

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 Model Number: ICF100
• Device Catalogue Number: ICF100
• Device Lot Number: BSLC7316
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 05/21/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2025
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/12/2025