MAUDE Adverse Event Report: ACIST MEDICAL SYSTEMS, INC. ACIST; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	KODAMA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On may 28, 2024, acist received information of this event via a user facility medwatch, report number mw5154670.The user facility reported the following: during a cardiac catheterization and intravascular ultrasound with the acist high-definition intravascular ultrasound (ivus) system, when the kodama catheter was removed from the patient's coronary artery, the orange tip fell off and stuck on the interventional wire inside the coronary artery.The medical professional inserted a snare, and the catheter piece was successfully removed from the patient's coronary artery.There was no injury to the patient.
Additional Manufacturer Narrative
The kodama catheter, lot 00349934, was requested but is not available as it was discarded by the user facility.A review of the device history record for lot 00349934 will be completed.Upon completion of the investigation, a follow-up report will be submitted to fda.
Additional Manufacturer Narrative
The manufacturing records of the catheter, lot number 00349934, used during the event were reviewed, and there were no quality or manufacturing issues during the manufacture of this lot.Per the kodama catheter instructions for use, the kodama catheter contains a short monorail guidewire engagement system.As such, it is susceptible to guidewire entanglement during catheter deployment and withdrawal.This may have been a contributing factor to this event, but we are unable to confirm the cause without physical investigation of the kodama catheter used in the event.

• Brand Name: ACIST
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): ACIST MEDICAL SYSTEMS, INC.; 7905 fuller road; eden prairie MN 55344
• Manufacturer (Section G): ACIST MEDICAL SYSTEMS, INC.; 7905 fuller road; eden prairie MN 55344
• Manufacturer Contact: teresa butler ; 7905 fuller road; eden praire, MN 55344 ; 9529959347
• MDR Report Key: 19608939
• Report Number: 2134243-2024-00010
• Device Sequence Number: 12792536
• Product Code: OBJ
• UDI-Device Identifier: 30841716102289
• UDI-Public: (01)30841716102289(11)210714(17)230714(10)03253589
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K132474
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: KODAMA
• Device Catalogue Number: 017788
• Device Lot Number: 00349934
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White