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

Model Number 45030

Device Problem Failure to Prime (1492)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of a solent dista thrombectomy.Visual inspection of the device revealed numerous kinks throughout the shaft of the catheter.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 screen, meaning that the device over-pressured.The shaft was inspected again by cutting the shaft at some of the more severe kinks but the hypotube had no damage and there was no reason that would have caused an over-pressure alarm.The device was removed from the console and the shaft was inspected again.The tip was cut and the jets were microscopically inspected and it showed that there was dried saline and blood so the device was sonic cleaned for 30 minutes to clear the jet holes.After sonic cleaning the device was ran again and once again over-pressured, so the jets were checked again and it was revealed that a jet hole 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 Description

Reportable based on device analysis completed on 20dec2019.It was reported that the catheter was unable to prime.An angiojet solent dista catheter was selected for a thrombectomy procedure.As the catheter was priming, it was unable to prime.After 18 seconds it stopped.The procedure was completed with another of the same device.There were no patient complications reported.However, device analysis revealed a plugged jet hole.

• Brand Name: ANGIOJET SOLENT DISTA
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9575172
• MDR Text Key: 178012310
• Report Number: 2134265-2019-16677
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K113363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/10/2020

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
• Device Operator: Health Professional
• Device Model Number: 45030
• Device Catalogue Number: 45030
• Device Lot Number: 0022614579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2019
• Initial Date FDA Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1