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	04/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 an error message occurred.An angiojet console and two angiojet spiroflex catheters were used in a thrombectomy procedure.During the procedure, the catheter was advanced however, a check for catheter kinks error occurred.The catheter was removed from the patient's body and replaced with a new spiroflex but the same error occurred.There were no patient complications reported.
Additional Manufacturer Narrative
B3: updated date of event.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 an error message occurred.An angiojet console and two angiojet spiroflex catheters were used in a thrombectomy procedure.During the procedure, the catheter was advanced however, a check for catheter kinks error occurred.The catheter was removed from the patient's body and replaced with a new spiroflex but the same error occurred.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
• MDR Report Key: 11755962
• Report Number: 2134265-2021-05370
• Device Sequence Number: 3438450
• Product Code: MCX
• UDI-Device Identifier: 08714729890584
• UDI-Public: 08714729890584
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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?: No
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1