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

Model Number	KODAMA
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Ventricular Fibrillation (2130); Thrombosis/Thrombus (4440)
Date of Event	09/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The kodama catheter used in the event was not returned to acist as it was discarded by the user facility.A review of the kodama catheter device history record (dhr) for this kodama lot 00213098 indicates there were no nonconformances or deviations associated with the manufacture of this lot.During the manufacture, samples were selected as part of the normal manufacturing process to measure tensile strength at bond locations throughout the distal tip and imaging window.All samples measured were above the tensile strength specification.All acceptance records demonstrate the device was manufactured in accordance with the device master record (dmr).Upon completion of acist's investigation of the event, a follow-up report will be submitted to fda.
Event or Problem Description
User facility report, during an intravascular ultrasound (ivus) procedure, using the acist hdi high-definition intravascular ultrasound (ivus) system and acist kodama intravascular ultrasound catheter on a patient with non-st-segment myocardial infarction, the kodama catheter became entrapped, and despite rotation and gentle withdrawal, the tip of the kodama catheter broke off and was retained in the patient's left anterior descending artery (lad).Subsequently, the patient had thrombosis of the left main coronary artery (lmca), ventricular fibrillation, cardiac arrest, and hypotension.After hemodynamic support and cardiopulmonary resuscitation (cpr), the patient's lmca was reopened and stented.Imaging suggested that an extruded piece of catheter fragment had been pulled back into the lmca.The catheter piece was stented.The patient was in critical condition post the event.
Additional Manufacturer Narrative
Images provided by the user facility were reviewed on 29 march 2021 by acist's medical advisory board member: the case report describes a fracture of the kodama catheter tip that lodged in the left main artery and caused thrombosis of the left main.This resulted in cardiac arrest.The vessel was re-opened and a stent was placed to re-open the vessel and trap the tip of the catheter against the wall of the vessel.The patient survived and was in stable but severe condition at the time of the report.There were four ivus pull back images and six freeze frame ivus images; as none of the images are labeled, it is difficult to make a conclusion from these images.A couple of the pull backs appear to be from the mid-left anterior descending (lad) or circumflex (cx) artery back through the left main.One image show a stent in the left main.There is mild fullness along one outer edge of the stent that may represent the tip of the kodama pressed against the vessel wall, however, this is not clear.There are not any angio runs included with the images provided.This report is considered closed.

• Brand Name: ACIST
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): ACIST MEDICAL SYSTEMS, INC.; 7905 fuller road; eden prairie MN 55344
• MDR Report Key: 10668217
• Report Number: 2134243-2020-00011
• Device Sequence Number: 19583207
• Product Code: OBJ
• UDI-Device Identifier: 30841716102289
• UDI-Public: (01)30841716102289(17)130322(10)00213098
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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 faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2020

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 Expiration Date: 03/22/2022
• Device Model Number: KODAMA
• Device Catalogue Number: 017788
• Device Lot Number: 00213098
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2020
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2 MM BALLOON; 7 FRENCH 45 CM BRITE TIP SHEATH; 7 FRENCH JL4 GUIDE; ASAHI SION BLUE GUIDEWIRE; BILAVIRUDIN; BMW WIRE; FIELDER XT WIRE HYDROPHILIC; TRAP LINER CATHETER; TURNPIKE LP CATHETER; TWINPASS CATHETER; WIGGLE WIRE
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 85 YR