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

Model Number 014667

Device Problems Break (1069); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2020

Event Type  malfunction  

Event Description

There was difficulty pulling the micro catheter back into the guide and it snapped inside the body.A second runthrough wire was then advanced to the distal lad next to the initial one.A balloon was advanced to the distal guide and inflated in an attempt to trap the ffr catheter in order to pull it but this was unsuccessful.Subsequently a 4mm and then 7mm snare was advanced over the wire but was not successful.A 3.0x20mm balloon was advanced to the distal guide, inflated and able to pull guide, wires and broken ffr catheter tip out of the body.Md believed the catheter was defective.No harm to patient.

• 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: 10008832
• MDR Text Key: 189328959
• Report Number: 10008832
• 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: 04/22/2020

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
• Device Operator: No Information
• Device Model Number: 014667
• Device Catalogue Number: 014667
• Device Lot Number: 0000125107
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/22/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24820 DA