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

Model Number	45030
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a solent dista thrombectomy system.The pump assembly, effluent/supply line, shaft, tip, and spike line were visually inspected.Blood was present inside the device and the waste bag was cut-off, when received.The waste bag was not returned for analysis.Inspection of the device revealed numerous kinks throughout the device.Functional testing was performed by placing the device in the angiojet ultra console.The complaint device failed to prime and the 'check saline supply' error was displayed on the console.The shaft and hypotube were microscopically examined and it was revealed that the shaft was kinked at the distal window with the hypotube separated at the jet body.The shaft was kinked causing the hypotube to become broken.When the hypotube is broken, the device will not prime and the console will continue to try and prime the catheter, causing 'check saline supply' error to display on the console and the device not to prime.
Event or Problem Description
Reportable based on device analysis on 24jun2020.It was reported that an error message occurred.An angiojet solent dista catheter was used for a thrombectomy procedure.During introduction of the device, it was noted that a "check saline supply" error message occurred.The procedure was completed with an angiojet solent omni catheter.No patient complications were reported.However, device analysis revealed a hypotube break.

• Brand Name: ANGIOJET SOLENT DISTA
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10234308
• Report Number: 2134265-2020-08949
• Device Sequence Number: 14238653
• Product Code: DXE
• UDI-Device Identifier: 08714729889731
• UDI-Public: 08714729889731
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K113363
• 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): 07/06/2020

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: Health Professional
• Device Expiration Date: 01/02/2022
• Device Model Number: 45030
• Device Catalogue Number: 45030
• Device Lot Number: 0025477375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 07/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1