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 Codes	Bradycardia (1751); Chest Pain (1776); Thrombosis/Thrombus (4440)
Date of Event	11/25/2021
Type of Reportable Event	Serious Injury
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 angio showing severe in-stent re-stenosis and the development of thrombus in the vessel after the passage of the intravascular ultrasound (ivus) kodama catheter that was subsequently treated with percutaneous transluminal coronary angioplasty (ptca), stenting, and anticoagulation.It is difficult to be sure when the ivus was performed, however, if all the images from the case are included in the set of images provided to acist, then it appears that there was evidence of thrombus in the left main and distal in the left anterior descending (lad) prior to dilation with the first balloon.Based on the information from the user facility, the ivus kodama catheter was used after this first dilation with a small balloon.The images after that balloon inflation and presumably after the ivus kodama catheter show occlusion of the lad in the mid segment.Presumably, this is what is then treated with administration of ic tirofiban and vasodilator.Flow is restored and stenting is performed with what appears to be a stable result on the final images.It appears there was the beginning of thrombus formation prior to ivus kodama catheter passage.If this is correct, then the presence of the ivus kodama catheter may have further exacerbated the formation of thrombus, but would not be the primary cause.
Event or Problem Description
During an angiography and intravascular ultrasound (ivus) procedure using the acist hdi hd ivus system with kodama catheter, the post ivus angio showed formation of thrombus at the lesion site in the left anterior descending (lad) artery.The patient was administered tirofiban and nicorandil via injection with subsequent development of bradycardia and chest pain.Subsequently, the lesion was stented.The final angio with and without wire showed no residual stenosis at the stent site and no thrombus, dissection, intimal flap with distal thrombolysis in myocardial infarction (timi) iii flow.
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: 14778033
• Report Number: 2134243-2022-00012
• Device Sequence Number: 5813123
• Product Code: OBJ
• UDI-Device Identifier: 30841716102289
• UDI-Public: (01)30841716102289(11)210714(17)230714(10)03253589
• Combination Product (Y/N): Y
• 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 GUIDING CATHETER 6FR; MINI TREK BALLOON 2.00X12MM; NC TREK BALLOON 3.00X8; NICORANDIL INJ; RUNTHROUGH NS PTCA GUIDEWIRE 0.014IN 180CM; TIROFIBAN INJ; XIENCE PRIME EVEROLIMUS ELUTING STENT 2.75X33MM
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian