MAUDE Adverse Event Report: ACIST MEDICAL SYSTEMS, INC. BT2000 AUTOMATED MANIFOLD KIT; INJECTOR AND SYRINGE, ANGIOGRAPHIC

Model Number	014613
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history coronary artery disease, chronic heart failure and shortness of breath.While have a diagnostic heart catheterization, the tubing came apart.This tubing is to be used under high pressure so should maintain its integrity.

• Brand Name: BT2000 AUTOMATED MANIFOLD 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: 10902672
• Report Number: 10902672
• Device Sequence Number: 1282933
• Product Code: DXT
• UDI-Device Identifier: 10841716101561
• UDI-Public: (01)10841716101561(11)200806(17)210813(10)21820P
• 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): 11/23/2020
• Report Date (Section F): 11/23/2020

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: No Information
• Device Model Number: 014613
• Device Lot Number: 21820P
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/25/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2020
• Patient Sequence Number: 1
• Patient Weight: 71
• Date Report Sent to FDA: 11/23/2020