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

Model Number 45038

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2019

Event Type  malfunction  

Event Description

It was reported that the device started pumping while the foot switch was not engaged.An angiojet ultra 5000a console was selected for use.The console started pumping while the foot switch was not engaged.The shielding was broken and the wires were exposed.No patient was involved.

Manufacturer Narrative

Device evaluated by mfr: the ultra system foot switch cable was received in bad condition with physical damages/defects observed.The ultra console foot switch failed mechanical inspection of the angiojet system functional feature test.The unit failed to pump when it was connected.A plate had a lot of scratches from overtime use and a cable with exposed wire.

Event Description

It was reported that the device started pumping while the foot switch was not engaged.An angiojet ultra 5000a console was selected for use.The console started pumping while the foot switch was not engaged.The shielding was broken and the wires were exposed.No patient was involved.

• 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: 8654372
• MDR Text Key: 146513192
• Report Number: 2134265-2019-06020
• 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: 08/14/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Initial Date Manufacturer Received: 05/08/2019
• Initial Date FDA Received: 05/30/2019
• Supplement Dates Manufacturer Received: 08/06/2019
• Supplement Dates FDA Received: 08/14/2019
• Removal/Correction Number: 92069759-FA
• Patient Sequence Number: 1