MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET ULTRA 5000A; CATHETER, CORONARY, ATHERECTOMY

Model Number	45038
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.An angiojet console was used in a thrombectomy procedure.During the preparation when placing the angiojet solent catheter into the console, the device showed an error 71.The procedure was cancelled.There were no patient complications reported.

• Brand Name: ANGIOJET ULTRA 5000A
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13939308
• Report Number: 2134265-2022-02405
• Device Sequence Number: 6468271
• Product Code: MCX
• UDI-Device Identifier: 08714729890584
• UDI-Public: 08714729890584
• Combination Product (Y/N): N
• Initial Reporter Country: UP
• PMA/510(K) Number: P980037
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2022

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: 08/07/2025
• Device Model Number: 45038
• Device Catalogue Number: 45038
• Device Lot Number: OEMTRACE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown