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	Thrombosis/Thrombus (4440)
Date of Event	12/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During an angiography and intravascular ultrasound (ivus) procedure using the acist hdi hd ivus system with kodama catheter, a thrombus had formed at the lesion site.The patient was administered tirofiban via injection, the lesion was then stented, and a final angiography was performed.There was no residual signs of stenosis or thrombosis at the stent site.
Additional Manufacturer Narrative
The acist kodama catheter, lot 00305575, used during the event was discarded by the user facility.A review of the device history record for lot 00305575 has been requested, and upon completion, a follow-up report will be submitted to fda.On (b)(6) 2022, the acist medical advisory board member provided the following clinical assessment: the information provided by the user facility describes an coronary angio with mid left anterior descending (lad) lesion that was treated first with a balloon and then intravascular ultrasound was performed.After ivus the information states thrombus was seen and it was treated with ic tirofiban, then stented with mid- and proximal-lad stents with good result.The films show an angio with a somewhat difficult to appreciate mid-lad lesion.This is dilated with balloon.There is visible thrombus in the vessel at this time.There are overlapping vessels making it more difficult to see the vessel and angioplasty site.Subsequently, the mid lad is stented with what looks like a stable result.Subsequently, images of the right coronary artery (rca) are acquired and some apparently abbreviated intervention is performed to the mid rca.Next, there are more images acquired of the lad showing evidence of thrombus in the proximal portion of the recently deployed stent.Another stent is placed proximally in overlapping fashion with what appears to be an adequate result in the lad but with occlusion of at least one diagonal at the intervention site.Based on review of the films it appears that the thrombus that formed was after mid-lad stenting and not immediately after ivus, making it less likely the ivus kodama catheter was causal in the thrombus formation.
Additional Manufacturer Narrative
A review of the device history record for kodama catheter lot 00305575 was completed on august 17, 2022.This review confirmed that there were no quality issues during manufacture of this device.Per the kodama user guide, thrombus formation is an adverse event that may occur because of intravascular ultrasound imaging.As with any interventional procedure, proper anticoagulation and anti-platelet therapy should be used per current guidelines.For patients who cannot receive heparin, substitute a dilution of the anticoagulant used for systemic anticoagulation.Acist's medical advisor requested information on the anticoagulation practices used by the user facility's physician involved in this event.No information has been received to date.

• 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: 14778039
• Report Number: 2134243-2022-00013
• Device Sequence Number: 5779337
• 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: IN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2021

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: 00305575
• 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: 05/05/2022
• Supplement Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: EBU 3.5 GUIDING CATHETER 6F; FIELDER XT PTCA GUIDEWIRE 0.014INX190CM; MINI TREK BALLOON 2.0X12MM; MINI TREK BALLOON 2.5X12MM; NC TREK BALLOON 3.00X8CM; NOSTRUM STENT 2.5X28MM; NOSTRUM STENT 3.0X36MM; RUNTHROUGH NS PTCA GUIDEWIRE 0.014X180CM
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian