MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (CE) ANGIOJET® ULTRA SYSTEM CONSOLE; CATHETER, CORONARY, ATHERECTOMY

Model Number 105650-037

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2017

Event Type  malfunction  

Manufacturer Narrative

"device expiration date - 12/31/9999." (b)(4).It is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported the foot pedal was sticking.During preparation for a deep vein thrombectomy treatment procedure of lower extremity veins, the physician was checking the angiojet® ultra system console when trying to prime an angiojet catheter, outside of the patient.The foot pedal was found stuck and would not recover.The physician stopped using the console and completed the case with manual aspiration.There were no reported complications and/or additional intervention.The patient was stable post procedure.

• Brand Name: ANGIOJET® ULTRA SYSTEM CONSOLE
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• Manufacturer (Section G): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6831538
• MDR Text Key: 84004854
• Report Number: 2134265-2017-08592
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: P980037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/09/2017

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: 105650-037
• Device Catalogue Number: 105650-037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2017
• Initial Date FDA Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2015
• 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