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

Model Number	KODAMA
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The kodama catheter, lot number 03253589, was received on (b)(6) 2021.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 high-definition intravascular ultrasound (ivus) system, model hdi, and acist kodama intravascular ultrasound catheter, the kodama catheter worked fine while performing the first few pullbacks in the right coronary artery (rca).The user experienced resistance while trying to advance and remove the kodama catheter from the obtuse marginal (om) artery and no pullbacks were performed.Subsequently, another run was attempted in the left circumflex (lcx) artery, but no image could be obtained.The catheter was removed from the lcx and resistance was also encountered.At the end of the case, a dissection was discovered in the left main artery.
Additional Manufacturer Narrative
The kodama catheter, lot number 03253589, was received on (b)(6), 2021.Tthe catheter was visually inspected and found to be free of defects.Functional testing was performed and there was no evidence of malfunction.On december 17, 2021 acist received additional information from the user facility.Per the user facility, the kodama catheter was not in use within the patient at the time of the arterial dissection.Based on this information, there is no evidence of a causal relationship between the kodama catheter and the patient dissection.

• Brand Name: ACIST
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR, 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: jeff audritsh ; 7905 fuller road; eden prairie, MN 55344 ; 9529959347
• MDR Report Key: 12988965
• Report Number: 2134243-2021-00022
• Device Sequence Number: 5984667
• 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: HK
• 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: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2021

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: 03253589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2021
• 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: Life Threatening
• Patient Sex: Unknown