MAUDE Adverse Event Report: ACIST MEDICAL SYSTEMS, INC. ANGIOTOUCH KIT; INJECTOR AND SYRINGE, ANGIOGRAPHIC

Model Number	014645
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure: left heart catheterization.When the package was opened for the acist/cvi angiotouch kit, there was not a male adapter on both ends.Product was not able to be used.

• Brand Name: ANGIOTOUCH KIT
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): ACIST MEDICAL SYSTEMS, INC.; 7905 fuller road; eden prairie MN 55344
• MDR Report Key: 18542352
• Report Number: 18542352
• Device Sequence Number: 9080966
• Product Code: DXT
• UDI-Device Identifier: 10841716102001
• UDI-Public: (01)10841716102001(11)231107(17)241120(10)31023P
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/05/2024
• Report Date (Section F): 01/05/2024

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: 014645
• Device Lot Number: 31023P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/19/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/19/2024
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/05/2024