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

Model Number	800962-006
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The acist kodama intravascular ultrasound catheter was requested to be sent to acist for investigation, but has not been received at this time.A review of the kodama catheter device history record (dhr) for this kodama catheter, lot 0088310, indicates there were zero non-conformances associated with the lot.The dhr review revealed no deviation of the device specifications or product process specifications.All acceptance records demonstrate the device was manufactured in accordance with the device master record.The user facility has not returned the suspect kodama catheter to acist.Acist is unsure whether the kodama catheter will return for investigation.If the catheter is returned, a follow-up report will be submitted.The cause of this event is unknown.
Event or Problem Description
The user facility reported that during a procedure utilizing the acist hdi high-definition intravascular ultrasound (ivus) system and acist kodama intravascular ultrasound catheter in a highly calcified left main artery, the tip of the kodama was detached inside the patient.There was no report of patient injury with this event.The physician used a snare in attempt to retrieve the tip, but was unsuccessful.The tip was successfully tacked to the vessel wall with a stent.The physician reported that three balloons had ruptured in the calcified, tortuous left main prior to ivus.

• Brand Name: ACIST KODAMA INTRAVASCULAR ULTRASOUND CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): ACIST MEDICAL SYSTEMS, INC.; 7905 fuller road; eden prairie MN 55344
• MDR Report Key: 6983535
• Report Number: 2134243-2017-00014
• Device Sequence Number: 13582934
• Product Code: OBJ
• UDI-Device Identifier: 10841716100755
• UDI-Public: (01)10841716100755(17)171107(10)0088310
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K113008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2017

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: 11/07/2017
• Device Model Number: 800962-006
• Device Catalogue Number: 017788
• Device Lot Number: 0088310
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2017
• Initial Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention