MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SPIROFLEX; CATHETER, EMBOLECTOMY

Model Number	10706
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Suction Problem (2170); Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an error message was displayed.An angiojet spiroflex catheter was selected for use.The system showed an error message indicating to replace the catheter.No patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of the spiroflex thrombectomy system.The pump, effluent/supply line, shaft, tip, piston, and spike line were visually inspected.Inspection of the device revealed numerous kinks throughout the shaft.Functional testing was performed by placing the device in the angiojet ultra console.Testing consisted of running the complaint device through the full priming cycle and 120 seconds in thrombectomy.The device ran within normal range without any leaks from the device or boot/pump assembly and there were no console errors/alarms.Product analysis did not confirm the reported event, as the device ran with no errors or issues during functional testing.
Event or Problem Description
It was reported that an error message was displayed.An angiojet spiroflex catheter was selected for use.The system showed an error message indicating to replace the catheter.No patient complications reported.

• Brand Name: ANGIOJET SPIROFLEX
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9539231
• Report Number: 2134265-2019-16069
• Device Sequence Number: 2341503
• Product Code: MCX
• UDI-Device Identifier: 08714729889380
• UDI-Public: 08714729889380
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K072769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2020

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: Other
• Device Expiration Date: 06/15/2021
• Device Model Number: 10706
• Device Catalogue Number: 10706
• Device Lot Number: 0024347867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1