MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET ULTRA 5000A; CATHETER, CORONARY, ATHERECTOMY

Model Number 45038

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2019

Event Type  malfunction  

Event Description

It was reported that loss of aspiration occurred.An angiojet console was used for a thrombectomy procedure.The device primed fine.However, the device was not suctioning or pumping fluid correctly during the procedure.No patient complications were reported.

• Brand Name: ANGIOJET ULTRA 5000A
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9574956
• MDR Text Key: 177407907
• Report Number: 2134265-2020-00064
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729890584
• UDI-Public: 08714729890584
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• 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: 45038
• Device Catalogue Number: 45038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2019
• Initial Date FDA Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1