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)
Date of Event	11/30/2016
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.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
Same case as: 2134265-2016-11873.It was reported that an error message displayed during aspiration.Three angiojet® solent¿ proxi catheters and an angiojet® ultra system console were selected for a thrombectomy procedure in the left arm fistula.The first catheter would not prime past 12 seconds.The second catheter primed.Aspiration was initiated for 20 seconds; however the device stopped and a check saline supply error message was displayed.The device appeared to be leaking from the base of the pump.The third catheter would not recognize the saline and displayed a "check saline" message and was unable to be primed.The procedure was completed with a balloon.There were no patient complications and the patient's condition was fine.
Additional Manufacturer Narrative
Device evaluated by mfr: the product was received in fair condition with no visible damage observed.The unit passed the functional test.The unit primed successfully.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
Same case as: 2134265-2016-11873.It was reported that an error message displayed during aspiration.Three angiojet® solent¿ proxi catheters and an angiojet® ultra system console were selected for a thrombectomy procedure in the left arm fistula.The first catheter would not prime past 12 seconds.The second catheter primed.Aspiration was initiated for 20 seconds; however the device stopped and a check saline supply error message was displayed.The device appeared to be leaking from the base of the pump.The third catheter would not recognize the saline and displayed a "check saline" message and was unable to be primed.The procedure was completed with a balloon.There were no patient complications and the patient's condition was fine.

• 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: 6181094
• Report Number: 2134265-2016-11998
• Device Sequence Number: 1025058
• Product Code: MCX
• UDI-Device Identifier: 08714729890607
• UDI-Public: (01)08714729890607(11)20160901
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2016

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: 105650-001R
• Device Catalogue Number: 105650-001R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2016
• Supplement Report FDA Received Date: 01/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1