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	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2022
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.
Event or Problem Description
During a percutaneous coronary intervention (pci), intravascular ultrasound (ivus) procedure using the acist hdi hd ivus system with kodama catheter, the tip of the kodama catheter broke and was visible on fluoroscopy.The kodama catheter was removed and the catheter tip was successfully retrieved from the patient with no harm to the patient.
Additional Manufacturer Narrative
Although requested, the kodama catheter was not returned to acist for investigation, as it had been discarded by the facility.Per review of the manufacturing records of the catheter lot number 304282 used during the event, there were no quality or manufacturing issues during the manufacture of this lot.Per the kodama catheter instructions for use, the kodama catheter contains a short monorail guidewire engagement system.As such, it is susceptible to guidewire entanglement and/or prolapse during catheter deployment and withdrawal.Movement of the catheter or guidewire against resistance may result in elongation or separation of the catheter or guidewire tip.The cause of this event is most likely guidewire entanglement or prolapse during employment or withdrawal of the kodama catheter, although we are unable to confirm this without investigation of the physical kodama catheter used in the event.

• 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 ; 9529959347
• MDR Report Key: 15910829
• Report Number: 2134243-2022-00022
• Device Sequence Number: 5362497
• Product Code: OBJ
• UDI-Device Identifier: 30841716102289
• UDI-Public: (01)30841716102289(11)210714(17)230714(10)03253589
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K132474
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2022

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: 00304282
• 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: 11/08/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2022
• 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: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Unknown