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

Model Number	45038
Medical Device Problem Codes	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	05/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.An angiojet ultra 5000a was used in a thrombectomy procedure.During the procedure, the unit was leaking and drawer assembly replacement was needed.The patient had been sedated.The procedure was not completed due to this event.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: angiojet drawer 5569 was received.The drawer was decontaminated.A visual inspection was done on the drawer and it failed visual inspection.The drawer is missing a backsplash and 2 screws.The a functional test was done on the drawer.It failed the functional test at the 100 cycles test.The complaint unit is leaking was confirmed.The most likely cause is a defective component which is the torsion spring.
Event or Problem Description
It was reported that the procedure was cancelled.An angiojet ultra 5000a was used in a thrombectomy procedure.During the procedure, the unit was leaking and drawer assembly replacement was needed.The patient had been sedated.The procedure was not completed due to this event.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; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14687748
• Report Number: 2134265-2022-06457
• Device Sequence Number: 4818364
• Product Code: MCX
• UDI-Device Identifier: 08714729890584
• UDI-Public: 08714729890584
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 10/04/2022

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 Model Number: 45038
• Device Catalogue Number: 45038
• Device Lot Number: U6958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2022
• Supplement Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2021
• 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