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

Model Number 105650-037

Device Problems Device Remains Activated (1525); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2016

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: over 18 years device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that the system could not be stopped when aspirating by the foot pedal.An angiojet ultra system console was selected for a venous thrombectomy procedure.The first part of the procedure was normal.After aspirating for 80 seconds, the foot pedal was released to prepare to stop aspiration.However, at this time, the system could not be stopped and it was still in running status.The keyboard was not responding, so the physician tried to shut down the system with the power button.The system was restarted and it changed the language from chinese to english and showed that the foot pedal was on.The console display showed: change the language.At this time only the power and alarm reset could be used.Then the physician changed the language and clicked "ap" after which the console showed "the aspiration volume 200cc, start the aspiration when the foot petal was off." the system could not be used and was shut down again.After one hour, the physician restarted the system.The system automatically switched to the priming procedure and showed an error message to "connect the saline supply." the pump cabinet could not be opened and the catheter could not be removed.After two hours, the physician restarted the system and the system automatically ran.The pump cabinet was opened and the catheter was removed.After the catheter was removed, the system displayed a message that said "illegally installed the catheter." the physician shut down the system and no further actions were taken.The procedure was not completed due to this event.There were no patient complications and the patient condition was noted as stable.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5866782
• MDR Text Key: 51827161
• Report Number: 2134265-2016-07461
• 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: Physician
• Type of Report: Initial
• Report Date: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• 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
• Date Manufacturer Received: 08/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2015
• 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