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

Model Number	OM-9000S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure, acrobat suv stabilizer system steel cable disintegrated and broke.
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, acrobat suv stabilizer system steel cable disintegrated and broke.They states that they went one click past.It was feeling loose when it should be tight, vice-versa.It reached the failure after tightening.The safety crimp was not-perpendicular to cable.There was not a struggle/difficulty to turn the knob.There were no visual abnormalities with any of the parts in the assembly.
Additional Manufacturer Narrative
Trackwise id#: (b)(4).Updated sections: b-4, b-5, d-4 - lot #/exp.Date, g-4, g-7, h-2, h-4, h-6, h-10, h-11.Corrected section: changed d-4 - catalog # from "om-9000s" to "c-om-9100s"; d-4 - udi # from "(b)(4).
Additional Manufacturer Narrative
Trackwise#: (b)(4).The device was returned to the factory for evaluation on 01/27/2023.An investigation was conducted on 02/09/2023.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed all over the device.The cable was observed to be detached from the device.The metal cable was observed to be shredded.There were no other visual defects observed.Based on the returned condition of the device as well as the evaluation results, the reported failure "break" was confirmed.The dhr, shop floor paperwork was reviewed.The vendor certifies that this device serial/lot conforms to all applicable product specifications.The lot # 3000250757 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.
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure, acrobat suv stabilizer system steel cable disintegrated and broke.They states that they went one click past.It was feeling loose when it should be tight, vice-versa.It reached the failure after tightening.The safety crimp was not perpendicular to cable.There was not a struggle/difficulty to turn the knob.There were no visual abnormalities with any of the parts in the assembly.Customer did not attribute any patient effects due to this issue.

• Brand Name: ACROBAT SUV STABILIZER
• Common Device Name: STABILIZER, HEART
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 16363144
• Report Number: 2242352-2023-00116
• Device Sequence Number: 17831877
• Product Code: MWS
• UDI-Device Identifier: 00607567700536
• UDI-Public: 00607567700536
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/06/2023

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: 06/29/2023
• Device Model Number: OM-9000S
• Device Catalogue Number: C-OM-9100S
• Device Lot Number: 3000250757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2023
• Supplement Date Received by Manufacturer: 02/17/2023; 04/11/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 03/16/2023; 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown