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

Model Number 105650-001

Device Problem Sticking (1597)

Patient Problem No Patient Involvement (2645)

Event Date 08/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the foot switch was sticking.An angiojet ultra system console was selected for use.During servicing, it was noted that the foot pedal was getting stuck and the cable looks worn down.There was no patient involved.

Manufacturer Narrative

Device evaluated by mfr: the product was returned for evaluation.Assembly foot switch cable was received in good condition with no physical damages observed.Angiojet ultra system console and catheter were not returned for evaluation.The foot switch cable was installed into pm angiojet, tested and passed.Priming did not stop and it didn't stick on all switch positional activation during the testing.A service history review was performed and nothing was found to indicate a possible service-related cause for the complaint.The most probable root cause of the reported difficulty is a supplier design constraint of the product.(b)(4).

Event Description

It was reported that the foot switch was sticking.An angiojet® ultra system console was selected for use.During servicing, it was noted that the foot pedal was getting stuck and the cable looks worn down.There was no patient involved.

• 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: 6859088
• MDR Text Key: 85811817
• Report Number: 2134265-2017-08978
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 08/20/2017

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: 105650-001
• Device Catalogue Number: 105650-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2017
• Initial Date FDA Received: 09/12/2017
• Supplement Dates Manufacturer Received: 09/22/2017
• Supplement Dates FDA Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 92069759-FA
• Patient Sequence Number: 1