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

Model Number 014644

Device Problems No Display/Image (1183); Unable to Obtain Readings (1516); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/08/2023

Event Type  Injury  

Event Description

Acist pressure tubing malfunctioning ao pressure suddenly disappeared during case requiring a different stopcook to regain a pressure measurement.Caitlin stated this stopcook comes in the same package as the acist tubing that is utilized to monitor arterial pressures during the procedure.Caitlin reported this brand of device has been used for a long time, and viscosity of contrast can affect the stopcook at times; however, caitlin has noticed a trend with the stopcooks recently in which they sometimes stop reading pressures when contrast has not even been injected.Caitlin is concerned that there may be a specific lot of stopcooks that are defective.

• Brand Name: ACIST ANGLOTOUCH KIT
• Type of Device: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): ACIST MEDICAL SYSTEMS, INC.
• MDR Report Key: 17004334
• MDR Text Key: 316054546
• Report Number: MW5117863
• Device Sequence Number: 1
• Product Code: DXT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 014644
• Device Lot Number: 01723U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White