MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SAN JOSE ANGIOJET® ULTRA SYSTEM CONSOLE; CATHETER, CORONARY, ATHERECTOMY

Model Number 105650-001

Device Problem Sticking (1597)

Patient Problem No Patient Involvement (2645)

Event Date 06/02/2018

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 preparation outside the patient, it was noted that the foot pedal worked intermittently and most probably was sticking.No error message displayed.

Event Description

It was reported that the foot switch was sticking.An angiojet ultra system console was selected for use.During preparation outside the patient, it was noted that the foot pedal worked intermittently and most probably was sticking.No error message displayed.

Manufacturer Narrative

Device evaluated by mfr: the ultra system foot switch cable was received in fair condition with no physical damages/defects observed.The unit passed the angiojet system functional feature test.The user interface display showed no system error on startup sequence during testing.The foot switch cable completed the prime cycle with no intermittent interruption.The unit did not confirm the issue after testing the pedal on any point of position.The device history record review was performed and nothing was found to indicate a possible service-related cause for the complaint.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

• Brand Name: ANGIOJET® ULTRA SYSTEM CONSOLE
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - SAN JOSE; 150 baytech drive; san jose CA 95134
• MDR Report Key: 7610944
• MDR Text Key: 111448863
• Report Number: 2134265-2018-05829
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• PMA/PMN Number: P980037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 06/04/2018

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
• Device Lot Number: U2040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 06/18/2018
• Supplement Dates Manufacturer Received: 07/10/2018
• Supplement Dates FDA Received: 08/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 92069759-FA
• Patient Sequence Number: 1