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

Model Number	OM-10000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure using acrobat-i stabilizer, as the device was being tightened using the knob, a metal piece "popped" off.The piece was retrieved and saved along with the device for return.The device was still used to complete procedure.There was no procedural delay.There was no patient injury.
Additional Manufacturer Narrative
(b)(4).Updated sections: b4,g3,g6,h2,h3,h6,h11.The device was returned to the factory for evaluation on 04/24/2025.An investigation was conducted on 04/29/2025.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.There were no visual defects observed on the returned device.The device was loaded onto a reference retractor with no physical or visual difficulties observed.The device was able to be locked onto the reference retractor.The flexlink arm was able to be adjusted and positioned, and then locked into place by turning the knob clockwise with no physical or visual difficulties, with the locking lever in both the locked and unlocked positions.The metal clip was returned for evaluation.Based on the condition of the device as well as the evaluation results, the reported failure "break" was confirmed.A manufacturing engineering evaluation was conducted.Acrobat i stabilizer devices observed to have stop bracket detachment.It was also visually observed that safety crimp location shifting in the slot, where stop bracket should have stayed intact to protect safety crimp residing under the mount and away from the link arm.All three devices were functional in terms of link arm being able to tighten and untighten using the knob.Safety crimp seen here should be placed towards the right and hidden under the housing, and "stop bracket" should be press fitted in this open cavity to secure the safety crimp.Based on the manufacturing engineering evaluation, the reported failure "break" was confirmed.The lot # 3000418354 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.

• Brand Name: ACROBAT-I STABILIZER
• Common Device Name: STABILIZER, HEART
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 21981849
• Report Number: 2242352-2025-0000536
• Device Sequence Number: 11840331
• Product Code: MWS
• UDI-Device Identifier: 00607567700581
• UDI-Public: (01)00607567700581(10)3000418354(17)260919
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2025

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: 09/19/2026
• Device Model Number: OM-10000
• Device Catalogue Number: OM-10000
• Device Lot Number: 3000418354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO CONCOMITANT PRODUCTS USED.
• Patient Sex: Unknown