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

Model Number	10707
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an error message was displayed.An angiojet spiroflex vg catheter was used for a thrombectomy procedure.However, the device would not suck saline in and alerted to replace with a new catheter.No patient complications were reported.

• Brand Name: ANGIOJET SPIROFLEX VG
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10504827
• Report Number: 2134265-2020-12022
• Device Sequence Number: 3222097
• Product Code: MCX
• UDI-Device Identifier: 08714729889441
• UDI-Public: 08714729889441
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K080806
• 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): 09/08/2020

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: 10/13/2021
• Device Model Number: 10707
• Device Catalogue Number: 10707
• Device Lot Number: 0025331314
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 09/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR