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

Model Number	45030
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number: either 22987931 or 23122126.Device evaluated by mfr.: returned product consisted of a solent dista thrombectomy.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, but the attached waste bag was new/not used as there was no fluid inside and it was still folded up.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.Further analysis revealed the obstructed jet hole was plugged with gold, which the jet body material is made of.Inspection of the remainder of the device revealed no damage or other irregularities.
Event or Problem Description
Reportable based on the device analysis on 12feb2020.It was reported that catheter failure to prime occurred.An angiojet solent dista catheter was selected for a thrombectomy procedure.However, during preparation, it was noted that the device would not prime.The procedure was completed with another of the same device.No patient complicaions were reported.However, returned device analysis revealed a plugged jet hole.

• 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: 9793038
• Report Number: 2134265-2020-02577
• Device Sequence Number: 2330628
• Product Code: DXE
• UDI-Device Identifier: 08714729889731
• UDI-Public: 08714729889731
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/05/2020

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: 06/15/2021
• Device Model Number: 45030
• Device Catalogue Number: 45030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 03/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1