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

Model Number SB-1000

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/11/2023

Event Type  malfunction  

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 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 Description

N/a.

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.

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 Description

N/a.

• Brand Name: ULTIMA ACTIVATOR II DRIVE MECHANISM
• Type of Device: 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
• MDR Text Key: 314497621
• Report Number: 2242352-2023-00347
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 00607567700215
• UDI-Public: 00607567700215
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.