MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (CE) ANGIOJET® ULTRA SYSTEM CONSOLE; CATHETER, CORONARY, ATHERECTOMY

Model Number	105650-001R
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Aspiration Issue (2883)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that an error message displayed during the procedure.An angiojet® ultra system console was selected for a thrombectomy procedure.During aspiration inside the patient, an error message displayed stating power supply out of range.The console was power cycled to recover from the error.The power to the system was on a dedicated out outlet.There were no patient complications and the patient status was good after the event.
Additional Manufacturer Narrative
Device evaluated by mfr.:the device was returned for analysis.The angiojet power supply switching, pfc board, and main control board were received in fair condition with no physical damages observed.These three units were installed into ultra system bench test fixture and passed functional test steps.The ultra system were reseated twice to verify the error but all units passed the functional test and the complaint was not able to duplicate.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).
Event or Problem Description
It was reported that an error message displayed during the procedure.An angiojet ultra system console was selected for a thrombectomy procedure.During aspiration inside the patient, an error message displayed stating power supply out of range.The console was power cycled to recover from the error.The power to the system was on a dedicated out outlet.There were no patient complications and the patient status was good after the event.

• Brand Name: ANGIOJET® ULTRA SYSTEM CONSOLE
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• MDR Report Key: 6841303
• Report Number: 2134265-2017-08889
• Device Sequence Number: 13481969
• Product Code: MCX
• UDI-Device Identifier: 08714729890607
• UDI-Public: 08714729890607
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2017

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: 105650-001R
• Device Catalogue Number: 105650-001R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Initial Date Received by Manufacturer: 08/11/2017
• Supplement Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 09/05/2017
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1