MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC ACROBAT V STABILIZER; STABILIZER, HEART

Model Number OM-9100S

Device Problem Mechanical Problem (1384)

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

Event Date 05/16/2023

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.H3 other text : device discarded.

Event Description

The hospital reported that during a coronary artery bypass procedure using acrobat v vacuum stabilizer system, std, one of the opcab blades from the om-9100s that fit on the ua-5001 activator drive would not lock in place.They noticed it at the beginning of the case.Completed case with device.No side effects.

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.The lot # 3000292899 history record review was completed.There were ncmrs , rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is a relation between the batch manufacturing process and the reported failure.

Event Description

N/a.

• Brand Name: ACROBAT V STABILIZER
• Type of Device: STABILIZER, HEART
• 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: 17081171
• MDR Text Key: 316723522
• Report Number: 2242352-2023-00467
• Device Sequence Number: 1
• Product Code: MWS
• UDI-Device Identifier: 00607567700536
• UDI-Public: 00607567700536
• 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
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2024
• Device Model Number: OM-9100S
• Device Catalogue Number: OM-9100S
• Device Lot Number: 3000292899
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/27/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male