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

Model Number	OM-10000
Medical Device Problem Codes	Mechanical Problem (1384); Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
N/a.
Additional Manufacturer Narrative
(b)(4) updated sections.Corrected section: h6-device code changed to 4039.The device was returned to the factory for evaluation on 01/09/2025.An investigation was conducted on 01/30/2025.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.There were no visual defects observed on the intact device.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 not secured in position when the knob was turned clockwise.The knob did not tightened the arm.A suction/vacuum strength test was performed per instructions of the vacuum leak test (mcv00012790 rev.A), using calibrated vacuum foot weight tlt2040708 (id: (b)(4);.75 lbs; and calibrated pressure gauge (id: (b)(4).The device passed the vacuum leak test, good vacuum was obtained and the baffle head was able to lift the weight.Based on the returned condition of the device "suction failure " was not confirmed but was confirmed for the analyzed failure 'positioning failure".The lot #3000410868 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.
Additional Manufacturer Narrative
Tw (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.
Event or Problem Description
It was reported during the procedure, the acrobat-i stabilizer suction cup couldn't attach to the patient's heart.Therefore, they replaced it with a new one.There were no procedural delays.No patient harm or injury reported.
Additional Manufacturer Narrative
(b)(4).Updated sections: b4,g3,g6,h2,h6,h11.Corrected section: h6-impact code 4629 removed.
Event or Problem Description
N/a.

• 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: 21107993
• Report Number: 2242352-2025-0000016
• Device Sequence Number: 8153801
• Product Code: MWS
• UDI-Device Identifier: 00607567700581
• UDI-Public: (01)00607567700581(10)3000410868(17)260726
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2025

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: 07/26/2026
• Device Model Number: OM-10000
• Device Catalogue Number: OM-10000
• Device Lot Number: 3000410868
• 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: 12/10/2024
• Supplement Date Received by Manufacturer: 03/19/2025; 04/01/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 03/19/2025; 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown