MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET ULTRA 5000A; CATHETER, CORONARY, ATHERECTOMY

Model Number 45038

Device Problem Failure to Disconnect (2541)

Patient Problem No Patient Involvement (2645)

Event Date 11/08/2018

Event Type  malfunction  

Event Description

It was reported that the foot switch is sticking.An angiojet ultra 5000a console was selected with no patient involved.The footswitch on the unit was sticking.The footswitch was clean and free from debris.

Event Description

It was reported that the foot switch is sticking.An angiojet ultra 5000a console was selected with no patient involved.The footswitch on the unit was sticking.The footswitch was clean and free from debris.Device evaluated by mfr: the ultra system foot switch was received in fair condition with no physical damages/defects observed.The ultra console foot switch passed functional feature test.The user interface display showed no system error on startup sequence during the testing.The console connected with the foot switch, passed the prime cycle, no sticking and physical inspection had no sign of failure.

• Brand Name: ANGIOJET ULTRA 5000A
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8119697
• MDR Text Key: 128894392
• Report Number: 2134265-2018-63352
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729890584
• UDI-Public: 08714729890584
• 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: 01/04/2019

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: 45038
• Device Catalogue Number: 45038
• Device Lot Number: U6488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 11/30/2018
• Supplement Dates Manufacturer Received: 12/14/2018
• Supplement Dates FDA Received: 01/04/2019
• Removal/Correction Number: 92069759-FA
• Patient Sequence Number: 1