MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC ULTIMA ACTIVATOR II DRIVE MECHANISM; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Model Number	SB-1000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.
Event or Problem Description
The hospital reported they were having issue with blades sb-1000 locking onto the ultima activator ii reusable drive mech.They used another sb-1000 to complete case.No case delay reported.No harm to patient reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Trackwise#: (b)(4).Specific actions for the reported failure mode are being maintained and documented under maquet's scar system.There were no consequences or impacts to the patient.
Additional Manufacturer Narrative
Trackwise#: (b)(4).Updated sections: b4, g4, g7, h2, h6, h10, h11.Corrected sections: d4--catalogue # corrected from "c-ua-5001" to "sb-1000" d4--unique identifier # corrected from "(b)(4)" to "(b)(4).A lot history record review was not performed as there were no lots shipped to the account within the date range of the ship history of the complaint.
Event or Problem Description
N/a.

• Brand Name: ULTIMA ACTIVATOR II DRIVE MECHANISM
• Common Device Name: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 16861759
• Report Number: 2242352-2023-00347
• Device Sequence Number: 5832677
• Product Code: DWS
• UDI-Device Identifier: 00607567700215
• UDI-Public: 00607567700215
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/16/2023

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 Model Number: SB-1000
• Device Catalogue Number: SB-1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 06/30/2023; 08/16/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 07/21/2023; 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Sex: Unknown