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

Model Number 45030

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a solent dista thrombectomy.The pump, effluent/supply line, shaft, tip, piston, and spike line were visually inspected.There was fluid in the attached waste bag, when received.There were numerous kinks throughout 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 over-pressure alarm was overridden on the console and the device was ran through the prime and thrombectomy mode.The device ran at a high-pressure; however, the device didn't leak.The device was removed from the console and the shaft was inspected again, but there were no kinks severe enough or reason that would have caused an over-pressure alarm.The shaft and tip were cut and the jets were microscopically inspected and it was revealed that a jet 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 12jun2019.It was reported that an error message occurred during device preparation.An angiojet solent dista catheter was selected for a thrombectomy procedure.During preparation, a "check saline supply error" message occurred.The device did not enter the patient's body.The procedure was completed with another of the same device.There were no patient complications reported.However, device analysis revealed a clogged jethole.

• 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: 8704044
• MDR Text Key: 148170090
• Report Number: 2134265-2019-06968
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 08714729889731
• UDI-Public: 08714729889731
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2021
• Device Model Number: 45030
• Device Catalogue Number: 45030
• Device Lot Number: 0023613331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2019
• 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