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

Model Number	XP-5000
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
The hospital reported that during a coronary artery bypass procedure, acrobat-i positioner could not properly attach to the patient¿s heart during use.As a result, they provided a replacement unit.The issue did not affect the patient or the surgical procedure.There were no delays in the procedure.
Additional Manufacturer Narrative
Tw # (b)(4).Updated sections: b4,d9,g3,g6,h2,h3,h6,h11.The device was returned to the factory for evaluation on 05/26/2025.An investigation was conducted on 7/2/2025.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the device.There were no visual defects observed on the device.A mechanical evaluation was conducted.The knob of the device was turned to tighten the flexarm link.The flexarm link did not tighten.A suction/vacuum strength test was performed per instructions of the vacuum leak test (mcv00001178), using calibrated vacuum weight tlt and calibrated pressure gauge.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 and the results of the investigation the reported failure "suction problem " was not confirmed, however, the analyzed failure "mechanical problem" was observed.A manufacturing engineering evaluation was conducted.The issue with the positioner not being able to attach to patient¿s heart was not confirmed.The complaint device did show signs of clinical use.The complaint device passed the suction/vacuum strength test per instructions of the vacuum leak test procedure mcv00001178.Therefore, suction problem was not confirmed as the vacuum was obtained and suction cup head was able to lift the weight and passed the vacuum leak test.During this investigation, complaints team observed a mechanical problem in the form of flex link arm not being able to tighten upon turning the knob to tighten the flex link arm and asked manufacturing engineering to further investigate.Manufacturing engineering investigated this potential mechanical failure by attaching the complaint device on the standard blade to replicate this mechanical failure of flex link arm not being able to tighten upon turning the knob in clockwise direction.Outcome of this test showed no sign of issues with complaint device being able to attach to the standard blade, remaining in locking position, and holding tension in the flex link arm upon turning the knob in clockwise direction.Therefore, mechanical failure of flex link arm not being able to tighten was not confirmed.Based on the manufacturing evaluation results, the reported failure "suction problem" was not confirmed and no analyzed failures were observed.The lot # 3000425826 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 or the analyzed failure.
Event or Problem Description
N/a.

• Brand Name: ACROBAT-I POSITIONER
• 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: 22191203
• Report Number: 2242352-2025-0000677
• Device Sequence Number: 8594286
• Product Code: MWS
• UDI-Device Identifier: 00607567700574
• UDI-Public: (01)00607567700574(10)3000425826(17)261009
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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 Model Number: XP-5000
• Device Catalogue Number: XP-5000
• Device Lot Number: 3000425826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown