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 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the foot switch was sticking.An angiojet® ultra system console was noted to have a sticking foot switch.The pedal was clean and free of debris.There was no visible damage to the foot pedal or cable.The issue did not occur during a procedure or with a patient.

Manufacturer Narrative

Device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes: updated.Device evaluated by mfr: the ultra system foot switch cable was received in fair condition with no physical damages/defects observed.The foot switch cable passed at steps of the angiojet system functional feature test.The user interface display showed no system error on startup sequence during the testing.Foot switch cable was very functional on every stroke position during prime cycle and passed the assembly test.A service history review was performed and nothing was found to indicate a possible service-related cause for the complaint.No past similar complaint for ultra system console sn:u3581 was found.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).

Event Description

It was reported that the foot switch was sticking.An angiojet® ultra system console was noted to have a sticking foot switch.The pedal was clean and free of debris.There was no visible damage to the foot pedal or cable.The issue did not occur during a procedure or with a patient.

• 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
• MDR Report Key: 7523462
• MDR Text Key: 108634385
• Report Number: 2134265-2018-04460
• 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: 04/24/2018

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: U3581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Initial Date Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 05/17/2018
• Supplement Dates Manufacturer Received: 07/26/2018
• Supplement Dates FDA Received: 08/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 92069759-FA
• Patient Sequence Number: 1