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

Model Number	45030
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by the manufacturer: returned product consisted of a solent dista thrombectomy system.The pump, effluent/supply line, shaft, tip, piston, and spike line were microscopically and visually inspected.Inspection of the device revealed that the shaft was kinked 6.5cm proximal of the tip.The hypotube at this location was broken.The separated ends of the hypotube were ovaled, indicating that the device was kinked prior to separation.The shaft was kinked causing the hypotube to become kinked and break.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 with the device not able to prime causing the boot to fill with fluid.Product analysis confirmed the reported event, as the shaft was kinked causing the hypotube to break and the device not to prime and boot to fill with fluid.
Event or Problem Description
Reportable based on device analysis completed on 27apr2020.It was reported that a boot leak occurred.An angiojet solent dista thrombectomy catheter was selected for use.During the procedure, while priming, a leak was noted on the bulb in the pump bag.The procedure was completed with a different device.No patient complications reported.However, returned device analysis revealed that the hypotube was broken 6.5 cm proximal of the tip.

• 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: 10005200
• Report Number: 2134265-2020-05672
• Device Sequence Number: 2857777
• Product Code: DXE
• UDI-Device Identifier: 08714729889731
• UDI-Public: 08714729889731
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/28/2020

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: 12/05/2021
• Device Model Number: 45030
• Device Catalogue Number: 45030
• Device Lot Number: 0025213032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR