MAUDE Adverse Event Report: ACIST MEDICAL SYSTEMS, INC. ACIST; OBJ

Model Number	KODAMA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The kodama catheter used during the event has been requested for investigation.Upon completion of the investigation, a follow-up report will be submitted to the fda.
Event or Problem Description
During an intravascular ultrasound (ivus) procedure, using the acist high-definition intravascular ultrasound (ivus) kodama catheter, the tip of the catheter fractured within the boston scientific guide wire.There were no reported adverse clinical effects to the patient.
Additional Manufacturer Narrative
The acist kodama catheter used during the event was investigated on 13 may 2025.The investigation indicated that the kodama catheter encountered some resistance during the catheter withdrawal and the imaging window was prolapsed with the guidewire.The catheter withdrawal against resistance must have resulted in the elongation of the imaging window and eventually the separation of the distal region of the imaging window.The manufacturing records for kodama catheter lot 00375064 were reviewed, and the catheter was manufactured to specification.A root cause of the reported event cannot be conclusively determined, but the cause appears to be use-related.Per the kodama catheter instructions for use: never advance or withdraw the kodama catheter against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the catheter or guidewire against resistance may result in elongation or separation of the catheter or guidewire tip, damage to the catheter, or vessel perforation.If resistance is met during catheter withdrawal, stop withdrawal and examine the guidewire and kodama catheter position under fluoroscopy.If the wire is entangled or prolapsed, withdraw the guidewire and the catheter as one system (simultaneously).

• Brand Name: ACIST
• Common Device Name: OBJ
• 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 ; 9529959300
• MDR Report Key: 21707729
• Report Number: 2134243-2025-00006
• Device Sequence Number: 9941942
• 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: AR
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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
• Operator of Device: Health Professional
• Device Model Number: KODAMA
• Device Catalogue Number: 017788
• Device Lot Number: 00349929
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ABBOT CO-PILOT BLEEDBACK CONTROL VALVE.; BOSTON SCIENTIFIC GUIDE WIRE.
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 93 KG