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

Model Number 105650-001

Device Problem Device Stops Intermittently (1599)

Patient Problem No Patient Involvement (2645)

Event Date 06/14/2016

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was not returned for evaluation.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The root cause has been determined to be wear and tear.(b)(4).

Event Description

It was reported an angiojet® ultra system console footswitch was working intermittently.No patient was involved.Additional information has been requested but has not been obtained.

• 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: 5786012
• MDR Text Key: 49292361
• Report Number: 2134265-2016-06142
• Device Sequence Number: 1
• Product Code: MCX
• 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: Health Professional
• Type of Report: Initial
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 105650-001
• Device Catalogue Number: 105650-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1