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

Model Number	45043
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a procedure was cancelled.An angiojet console was selected for thrombectomy procedure.However, during the use of the unit, it was noticed that there was liquid leaking and suspected a bad drawer assembly.The procedure was not completed due to this event.No further complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was not returned for evaluation.However, an in field work order was reviewed as part of this investigation.The unit was observed leaking and suspected to be a bad drawer assembly.A boston scientific field service engineer (fse) visited the site on 20feb2023.The replacement part was delivered to the customer site to install the component.After install, the new component would not calibrate, and the new component was deemed faulty and would not work.On 22feb2023 the fse returned to the customer site and installed a new drawer component.The console was verified to be functional, and unit is ready for use.
Event or Problem Description
It was reported that a procedure was cancelled.An angiojet console was selected for thrombectomy procedure.However, during the use of the unit, it was noticed that there was liquid leaking and suspected a bad drawer assembly.The procedure was not completed due to this event.No further complications were 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; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16007000
• Report Number: 2124215-2022-52490
• Device Sequence Number: 5620037
• Product Code: MCX
• UDI-Device Identifier: 08714729890607
• UDI-Public: 08714729890607
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2023

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 Model Number: 45043
• Device Catalogue Number: 45043
• Device Lot Number: U4485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2022
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown