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

Model Number	ACROBAT SUV STABILIZER SYSTEM
Medical Device Problem Codes	Positioning Failure (1158); Suction Failure (4039)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id # (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 suv stabilizer system.Doctor stated that the stabilizer foot suction cups do not hold onto the heart and said that the foot keeps moving while he is sewing.No patient effects and he continued with stabilizer to finish case.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
(b)(4).Corrected sections: h6--clinical code.The device was returned to the factory for evaluation on 11/16/2020.An investigation was conduced on 11/17/2022.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the device.There were no visual defects observed.The device was evaluated for its mechanical function.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 did tightened the arm.When the locking lever was locked, the device was able to be locked on the reference retractor.A suction/vacuum strength test was performed per instructions of the vacuum leak test (mcv00001178 rev.A), using calibrated vacuum weight tlt (id: 14272; 2 lbs; due 31-mar-2023) and calibrated pressure gauge (id: 14275; due 30-apr-2023).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 as well as the evaluation results, the reported failures "positioning failure" and "suction failure" were not confirmed.The lot # 3000128443 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 SUV STABILIZER SYSTEM
• 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: 10869091
• Report Number: 2242352-2020-01010
• Device Sequence Number: 2962967
• Product Code: MWS
• UDI-Device Identifier: 00607567900004
• UDI-Public: 00607567900004
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (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): 11/21/2022

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: ACROBAT SUV STABILIZER SYSTEM
• Device Catalogue Number: OM-9000S
• Device Lot Number: 3000128443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 89 KG