MAUDE Adverse Event Report: enableCV, LLC enableCV Thin-Flex¿ Single Stage Venous Drainage Cannula; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	TF024O90
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Reduced Blood Flow (4598)
Date of Event	07/07/2026
Type of Reportable Event	Malfunction

• Brand Name: enableCV Thin-Flex¿ Single Stage Venous Drainage Cannula
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): enableCV, LLC; 6967 s. river gate dr; ste 104; midvale UT 84047
• Manufacturer (Section G): enableCV, LLC; 6967 s. river gate dr; ste 104; midvale UT 84047
• Manufacturer Contact: dannette crooms ; 6967 s. river gate dr; ste 104; midvale, UT 84047 ; +1(801)842-4930
• MDR Report Key: 50161434
• Report Number: 3031571797-2026-00021
• Device Sequence Number: 18461125
• Product Code: DWF
• UDI-Device Identifier: 00840479400716
• UDI-Public: 00840479400716
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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: TF024O90
• Device Lot Number: 469993
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/20/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2025
• 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