MAUDE Adverse Event Report: ACIST MEDICAL SYSTEMS, INC. ACIST; CATHETER, ULTRASOUND, INTRAVASCULAR, PRODUCT CODE: OBJ, PRODUCT CODE: OBJ, PRODU

Model Number	KODAMA
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The kodama catheter was received at acist.Upon completion of investigation, a follow-up report will be submitted to fda.
Event or Problem Description
On (b)(6) 2024, the user facility reported that the tips of two acist high definition intravascular ultrasound (ivus) kodama catheters had broken and that the catheters had not been used on a patient.Acist requested additional information on the event, and on march 5, 2024 the user facility reported that the tip of one kodama catheter was broken after it was used in a patient during an ivus procedure.The user facility reported that this was not a routine ivus procedure.The patient had an occluded stent and peripheral was used to observe, and then the physician decided to perform ivus.The physician started the ivus procedure with an 0.18 wire and navi.Then the physician switched to a different wire (platinum plus) to attempt to get the kodama catheter over but the platinum plus was prolapsing.The physician kept the kodama catheter within the patient vasculature and then used another catheter to keep the wire from prolapsing and to keep moving forward with the kodama catheter.When this wasn't working, the physician tried to pull the kodama catheter off the wire.The physician removed the wire and catheters from the patient and found the kodama catheter tip had broken.It is possible that the tip was damaged during the procedure.
Additional Manufacturer Narrative
Initial information from the user facility reported a single catheter was used but two catheters were received from the user facility.Both kodama catheters are lot 00340011.There was no report of patient injury during the use of either of the two kodama catheters.The investigation of the two catheters was completed on 7 may 2024.Visual verification of both catheters confirmed tip separation.The device history record (dhr) for lot 00340011 was reviewed, revealing no deviations of the device specifications, product process specification(s), quality assurance procedures(s) and specification(s).All records demonstrate the device was manufactured in accordance with the device master record.Per the acist hdi / kodama user guide: the kodama catheter is to be used in conjunction with standard protocols for vascular cannulation.The kodama catheter is designed for use with a 0.014 in (0.36 mm) diameter guidewire approved for intravascular use and an approved 6 fr to 8 fr guide catheter or 5 fr or larger guide sheath with a minimum internal diameter of 0.064 in (1.63 mm).The user facility reported that they used a 0.018 in platinum plus guidewire.

• Brand Name: ACIST
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR, PRODUCT CODE: OBJ, PRODUCT CODE: OBJ, PRODU
• 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 55344 ; 9529959347
• MDR Report Key: 19116802
• Report Number: 2134243-2024-00004
• Device Sequence Number: 12687499
• Product Code: OBJ
• UDI-Device Identifier: 30841716102289
• UDI-Public: (01)30841716102289(11)210714(17)230714(10)03253589
• Combination Product (Y/N): N
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2024

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: 00340011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2023
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NAVI CATHETER; PLATINUM PLUS GUIDE WIRE
• Patient Sex: Unknown