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	04/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a solent dista thrombectomy.Visual inspection of the device revealed no damage or irregularities to the device.Functional testing was performed by placing the device in the angiojet console.The device failed to prime and the 'check catheter for kinks' error was displayed on the console, meaning that the device over-pressured.The shaft was inspected but there was no kinks or other reason that would have caused an over-pressure alarm.The markerband, shaft, and tip were cut-off, and the jets were microscopically inspected.Inspection of the jet holes showed that there was a jet hole that was plugged, causing the over pressure as the flow was being restricted.Further analysis revealed that 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 device analysis completed on 04jun2020.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 catheter would not prime.The procedure was completed with a different catheter.No patient complications 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: 10167816
• Report Number: 2134265-2020-08182
• Device Sequence Number: 19361833
• Product Code: DXE
• UDI-Device Identifier: 08714729889731
• UDI-Public: 08714729889731
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/18/2020

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: 0025275157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1