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

Model Number	45038
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the foot pedal malfunctioned.The foot pedal on an (b)(4) console would activate without user input when a catheter is inserted into the console.The foot pedal was replaced.There was no patient involvement.
Additional Manufacturer Narrative
Device evaluated by mfr.: the ultra console foot switch cable was received by san jose cis in bad condition with physical damages/defects observed.The unit failed visual and mechanical inspection on bent connector pins therefore because of this, the clinical observation was confirmed.
Event or Problem Description
It was reported that the foot pedal malfunctioned.The foot pedal on an angiojet ultra 5000a console would activate without user input when a catheter is inserted into the console.The foot pedal was replaced.There was no patient involvement.

• Brand Name: ANGIOJET ULTRA 5000A
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11484756
• Report Number: 2134265-2021-03194
• Device Sequence Number: 3412346
• Product Code: MCX
• UDI-Device Identifier: 08714729890584
• UDI-Public: 08714729890584
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/07/2025
• Device Model Number: 45038
• Device Catalogue Number: 45038
• Device Lot Number: OEMTRACE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1