MAUDE Adverse Event Report: ACIST MEDICAL SYSTEMS, INC. ACIST NAVVUS CATHETER; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number 014667

Device Problem Device Sensing Problem (2917)

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

Event Date 02/22/2022

Event Type  malfunction  

Event Description

No pressure from ffr wire being transduced.There was no harm to the patient.Manufacturer response for catheter, acist navvus catheter (per site reporter) clinical site reported to the manufacturer directly.

• Brand Name: ACIST NAVVUS CATHETER
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): ACIST MEDICAL SYSTEMS, INC.; 7905 fuller road; eden prairie MN 55344
• MDR Report Key: 14407025
• MDR Text Key: 291715815
• Report Number: 14407025
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 014667
• Device Lot Number: 0000169040
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/05/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other