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

Model Number	OM-9000Z
Medical Device Problem Codes	Mechanical Problem (1384); Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure after the thoracotomy, acrobat suv vacuum stabilizer system, st arm would not stay in place no matter how much the knob was turned.The suction was also weak and it could not be fixed to the area.A new device was opened to complete the procedure.There was no major delay.There was no patient harm.
Additional Manufacturer Narrative
Trackwise id # (b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
Additional Manufacturer Narrative
Trackwise #(b)(4).Updated sections: b4, d9, g4, g7, h2, h3, h6, h11.The investigation has been started since the complaint was received, the following contents have been conducted: 1.Dhr review: the dhr of the reported lot has been reviewed.No non-conformity relevant with the reported issue is observed.All the products had been performed 100% function test during production.They all passed the function test which demonstrate the knob can be tightened and can also tighten the flexlink arm, and the suction works normally.2.Trend review: in the last 12 months, the occurrence rate is (b)(4) (for knob not tighten) and (b)(4) (for suction weak) which is under anticipated occurrence rate.3.The device was received and evaluated for a visual inspection, signs of clinical use and evidence of blood were observed on the device.There were no visual defects observed on the device.A mechanical evaluation was conducted.The device was securely assembled onto a reference retractor blade by sliding the stabilizer base onto the rail and locking the lever.The knob was evaluated for its ability to tighten the flexlink arm while the locking lever was in both the locked and unlocked positions.The flexlink arm was secured in position when the knob was turned clockwise.The knob can tighten the arm.When the locking lever was locked, the device was able to be locked on the reference retractor.4.The suction function of the returned device was evaluated by connecting the device to the test system following label instructions, the test result indicated malleable stabilizer foot can lift the weight as required in manufacture working instruction (mp-bh-0049), suction works normally.Based on the returned condition of the device as well as the evaluation results, the reported failure "the arm would not stay in place " and ¿suction weak¿ was not confirmed.There were no ncmrs, rework, or deviations documented for the reported batch, based on above review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.
Event or Problem Description
N/a.

• Brand Name: ACROBAT SUV 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: 20691212
• Report Number: 2242352-2024-0001247
• Device Sequence Number: 15261405
• Product Code: MWS
• UDI-Device Identifier: 00607567900004
• UDI-Public: (01)00607567900004(10)3000412741(17)260802
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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: 08/02/2026
• Device Model Number: OM-9000Z
• Device Catalogue Number: OM-9000Z
• Device Lot Number: 3000412741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown