MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET XMI; CATHETER, EMBOLECTOMY

Model Number	10708
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an error message occurred during procedure.An angiojet xmi catheter was selected for use for a thrombectomy procedure in the popliteal artery.When the physician attempted thrombectomy in the artery, the console displayed an error message "check kinks" and the catheter only did about 20 more pumps.The physician removed the catheter from the patent and used another angiojet xmi catheter to complete the procedure.There were no patient complications reported and the patient's status post procedure was fine.

• Brand Name: ANGIOJET XMI
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7951842
• Report Number: 2134265-2018-61741
• Device Sequence Number: 13750570
• Product Code: MCX
• UDI-Device Identifier: 08714729889151
• UDI-Public: 08714729889151
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/30/2020
• Device Model Number: 10708
• Device Catalogue Number: 10708
• Device Lot Number: 0022505170
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1