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

Model Number	45027
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a zelantedvt thrombectomy system.The pump number was reviewed in sap and confirmed to be from finished goods batch, which matches the reported batch number.The pump, effluent/supply line, shaft, tip, piston, and spike line were microscopically and visually inspected.Inspection of the device presented no damage or irregularities to the device.Functional testing was performed by placing the device in the angiojet console.The complaint device failed to prime and the 'check catheter for kinks' error was displayed on the console, meaning that the device over-pressured.The device was removed from the console and the shaft was inspected but there was no reason that would have caused an over-pressure alarm.The tip was cut, and the jets were microscopically inspected, and it showed that there was a jet hole that was plugged, causing the over pressure as the flow was being restricted.The jet body was cut-off from the device.Additional testing was performed on the plugged jet hole.The eds identified that the source of the fm that was obstructing the jet hole was identified as stainless steel, which the jet body material is made of.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2020.It was reported that the catheter was unable to prime.An angiojet zelanted vt catheter was selected for a deep venous thrombosis procedure.The catheter would not prime properly and it did not entered the patient's body.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed a plugged jet hole.

• 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: 9860641
• Report Number: 2134265-2020-03641
• Device Sequence Number: 14310785
• Product Code: KRA
• UDI-Device Identifier: 08714729904724
• UDI-Public: 08714729904724
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2020

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 Model Number: 45027
• Device Catalogue Number: 45027
• Device Lot Number: 0024207805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1