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

Model Number	45027
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a zelante thrombectomy system.The pump assembly, effluent/supply line, shaft, tip, and spike line were microscopically and visually inspected.Blood was present inside the device and 200ml of blood in the attached waste bag and the boot was full of fluid, when received.Inspection of the device revealed that the shaft was severely kinked 24cm distal of the strain relief.The device was placed in the x-ray to inspect the hypotube at the location of the kink, when it was revealed that the hypotube was separated.The separated ends of the hypotube were ovaled, indicating that the hypotube was kinked prior to separation.The shaft was kinked causing the hypotube to become kinked and separated.When the hypotube is separated, 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.When the device will continue to try and be primed, the boot will fill up with fluid and eventually leaking out the manufactured vent hole if too full, making it appear that there is a leak at the pump site.
Event or Problem Description
Reportable based on device analysis completed on 02-november-2020.It was reported that the pump boot was leaking.An angiojet zelantedvt catheter was used in a thrombectomy procedure.During preparation, it was noted that the catheter was leaking at the bulb.The procedure was completed with a different device.No patient complications were reported.However, returned device analysis revealed a hypotube break.

• Brand Name: ANGIOJET ZELANTEDVT
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10891005
• Report Number: 2134265-2020-16324
• Device Sequence Number: 11470336
• Product Code: KRA
• UDI-Device Identifier: 08714729904724
• UDI-Public: 08714729904724
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151313
• 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): 11/23/2020

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: 01/21/2022
• Device Model Number: 45027
• Device Catalogue Number: 45027
• Device Lot Number: 0025225130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1