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

Model Number	45038
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that the procedure could not be completed.An angiojet console was selected for use.However, it was noted that the roller pump refused to work.Due to this issue, the procedure could not be completed.No patient complications were reported.
Additional Manufacturer Narrative
B3: date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that the procedure could not be completed.An angiojet console was selected for use.However, it was noted that the roller pump refused to work.Due to this issue, the procedure could not be completed.No patient complications were reported.It was further reported that the device kept giving a roller pump error and would not load the catheter.The procedure was completed with a non-bsc device.
Additional Manufacturer Narrative
B3: date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr: the angiojet ultra 5000a was returned for analysis.The work order confirmed that the drawer assembly contributed to the reported event and after fse repair/replacement was complete the console functioned as intended.
Event or Problem Description
It was reported that the procedure could not be completed.An angiojet console was selected for use.However, it was noted that the roller pump refused to work.Due to this issue, the procedure could not be completed.No patient complications were reported.It was further reported that the device kept giving a roller pump error and would not load the catheter.The procedure was completed with a non-bsc device.

• 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): BOSTON SCIENTIFIC CORPORATION; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19203615
• Report Number: 2124215-2024-25227
• Device Sequence Number: 8072403
• Product Code: MCX
• UDI-Device Identifier: 08714729890584
• UDI-Public: 08714729890584
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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,Followup
• Report Date (Section B): 07/18/2024

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 Model Number: 45038
• Device Catalogue Number: 45038
• Device Lot Number: U6367
• 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: 04/05/2024
• Supplement Date Received by Manufacturer: 04/26/2024; 06/26/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 05/20/2024; 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2016
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown