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

Model Number	45043
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.An angiojet ultra 5000a console was selected for use.During preparation, the unit was leaking and the drawer was suspected to be defective.The procedure was cancelled due to this event.No patient complications were reported.
Event or Problem Description
It was reported that the procedure was cancelled.An angiojet ultra 5000a console was selected for use.During preparation, the unit was leaking and the drawer was suspected to be defective.The procedure was cancelled due to this event.No patient complications were reported.It was further reported that error 69 and 43 occurred.
Event or Problem Description
It was reported that the procedure was cancelled.An angiojet ultra 5000a console was selected for use.During preparation, the unit was leaking and the drawer was suspected to be defective.The procedure was cancelled due to this event.No patient complications were reported.It was further reported that error 69 and 43 occurred.
Additional Manufacturer Narrative
Device evaluated by mfr: angiojet drawer was received.The drawer was decontaminated.A visual inspection was done on the drawer, and it failed because it is missing 2 screws.Then a functional test was done on the drawer.It passed the functional test.
Additional Manufacturer Narrative
Device evaluated by mfr: angiojet console (b)(6) was also received and decontaminated.The console failed visual inspection because one of the bag holder assemblies was broken.Then a functional test was done on the console.It failed the functional test by booting up to error code 56.This resulted in product failure, confirming the complaint.Device evaluated by mfr: angiojet drawer was received.The drawer was decontaminated.A visual inspection was done on the drawer, and it failed because it is missing 2 screws.Then a functional test was done on the drawer.It passed the functional test.
Event or Problem Description
It was reported that the procedure was cancelled.An angiojet ultra 5000a console was selected for use.During preparation, the unit was leaking and the drawer was suspected to be defective.The procedure was cancelled due to this event.No patient complications were reported.

• Brand Name: ANGIOJET ULTRA 5000A
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BAYER INTERVENTIONAL; 8880 evergreen blvd; coon rapids MN 55433
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 16327693
• Report Number: 2124215-2023-04613
• Device Sequence Number: 7828277
• Product Code: MCX
• UDI-Device Identifier: 08714729890607
• UDI-Public: 08714729890607
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/09/2023

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: 45043
• Device Catalogue Number: 45043
• Device Lot Number: U2535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/16/2023
• Supplement Date Received by Manufacturer: 02/10/2023; 03/31/2023; 09/13/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 03/06/2023; 04/24/2023; 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown