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

Model Number	45032
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 17-nov-2018.It was reported that the catheter leaked during preparation of the device.An angiojet solent proxi catheter was selected for a thrombectomy procedure.During preparation, the device was being primed and the catheter leaked.It was unknown the location of the leak.The procedure was completed with another of the same device.There were no patient complications reported.The returned product consisted of a solent proxi thrombectomy system.The pump, spike line, effluent/supply line, shaft and tip were microscopically and visually inspected.There were numerous kinks throughout the device.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 in thrombectomy mode.The device ran within normal range (10.05 kpsi) without any errors or alarms; however, fluid did leak from the shaft.The shaft was microscopically inspected and a hole in the shaft was revealed 44.2cm distal of the strain relief.Inspection of the remainder of the device presented no other 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: 8091999
• Report Number: 2134265-2018-63029
• Device Sequence Number: 1498290
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2018

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: 07/19/2020
• Device Model Number: 45032
• Device Catalogue Number: 45032
• Device Lot Number: 0022661127
• 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: 11/17/2018
• Initial Report FDA Received Date: 11/20/2018
• Patient Sequence Number: 1