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

Model Number	KODAMA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The kodama catheter, lot number 00318197, was received on 19jan2023.Upon completion of the investigation, a follow-up report will be submitted to fda.
Event or Problem Description
During an intravascular ultrasound (ivus) procedure using the acist kodama catheter, the tip broke within patient.The tip was removed by the physician and there was no injury to the patient.
Additional Manufacturer Narrative
Investigation of the kodama catheter, lot 00318197, was completed on 8 june 2023.Visual verification of the tip and part of the imaging window was separated from the sheath assembly.The imaging window was elongated and damaged starting from the proximal end of the vent hole indicating a potential guidewire entrapment had occurred during the catheter removal.The device history record (dhr) for lot 00318197 was reviewed, revealing no deviation of the device specifications, product process specification(s), the quality assurance procedure(s) and specification(s).All acceptance records demonstrate the device was manufactured in accordance with the device master record.An assignable cause could not be indentified.Correction to b1, adverse event.In the initial report, this was incorrectly selected as product problem.Correction to b2, required intervention.In the initial report, this was incorrectly selected as hospitalization.

• Brand Name: ACIST
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR, PRODUCT CODE: OBJ, PRODUCT CODE: 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 prairie, MN 55344 ; 9529959300
• MDR Report Key: 16287216
• Report Number: 2134243-2023-00002
• Device Sequence Number: 17453439
• Product Code: OBJ
• UDI-Device Identifier: 30841716102289
• UDI-Public: (01)30841716102289(AA)210714(17)230714(10)03253589
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113008
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: KODAMA
• Device Catalogue Number: 017788
• Device Lot Number: 00318197
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2022
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown