MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SOLENT PROXI; CATHETER, CONTINUOUS FLUSH

Model Number	45032
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a loss of aspiration occurred during use.An angiojet solent proxi catheter was selected for a thrombectomy procedure in the superficial femoral artery.During thrombectomy mode, the catheter did not suck the thrombus.No error message displayed.There were no visual defects noted on the device.The procedure was completed with a different device.There were no patient complications and the patient's status is fine.Device evaluated by mfr: the pump assembly, effluent/supply line, shaft, tip, piston, and spike line were visually inspected.Blood was present outside and inside the device.The waste bag was cut-off, when received.The waste bag was not returned for analysis.Functional testing was performed by placing the device in the angiojet ultra console.Functional testing consisted of running the complaint device through the full priming cycle and 180 seconds in thrombectomy mode.The device ran within normal range, without any leaks, issues or alarms.The device sucked normally and there was no issues with the aspiration.Inspection of the device presented no damage or irregularities.

• Brand Name: ANGIOJET SOLENT PROXI
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8080770
• Report Number: 2134265-2018-62927
• Device Sequence Number: 13834903
• Product Code: DXE
• UDI-Device Identifier: 08714729889595
• UDI-Public: 08714729889595
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101406
• 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
• Report Date (Section B): 11/16/2018

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: 08/31/2020
• Device Model Number: 45032
• Device Catalogue Number: 45032
• Device Lot Number: 0022826471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 11/16/2018
• Patient Sequence Number: 1
• Patient Age: 65 YR