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	09/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that error 72 occurred and the procedure was cancelled/rescheduled.An angiojet ultra 5000a was selected for use in a thrombectomy procedure.However, during the procedure, the device alerted an error 72 message.Unable to clear the procedure, the case was aborted.No patient complications were reported.
Event or Problem Description
It was reported that error 72 occurred and the procedure was cancelled/rescheduled.An angiojet ultra 5000a was selected for use in a thrombectomy procedure.However, during the procedure, the device alerted an error 72 message.Unable to clear the procedure, the case was aborted.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: angiojet drawer u3704 and main controller board was received.Console and drawer were decontaminated.A visual inspection was done on drawer and passed inspection.Console failed visual inspection for missing kapton tape.Functional test performed on the returned main board, and it passed the functional test.Then, a functional test was done on the drawer, and the drawer passed the functional test.Console failed functional test for showing the error 72; actuator sensor pca board connector socket to the main board was loose.Console pass functional test without showing error 72 after connection was secured.No other issues were identified during the product analysis.

• 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: 20345869
• Report Number: 2124215-2024-61021
• Device Sequence Number: 12749028
• Product Code: MCX
• UDI-Device Identifier: 08714729890584
• UDI-Public: 08714729890584
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male