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

Model Number REF 014667

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2019

Event Type  Injury  

Event Description

Attempted to ffr (fractional flow reserve) posterior descending artery.Tip of catheter broke off into the proximal to mid portion of the right coronary artery.Inflated a balloon on a separate wire and pulled the tip back into the guiding catheter.Send defective catheter back to mfr for evaluation.Proceeded to finish the pci of the lad artery.No harm.

• Brand Name: ACIST NAVVUS FFR CATHETER
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): ACIST MEDICAL SYSTEMS, INC.
• Manufacturer Contact: 7905 fuller road; eden prairie,, MN 55344 ; 1-888-670-
• MDR Report Key: 8428327
• MDR Text Key: 139209533
• Report Number: MW5084958
• Device Sequence Number: 1
• Product Code: DXO
• 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: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2020
• Device Model Number: REF 014667
• Device Lot Number: 0000106138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 66