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

Model Number	OM-9100S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The hospital reported that during preparation for a coronary artery bypass procedure, acrobat v stabilizer system internal steel cable snapped.It broke while they were prepping for anastamosis.They were turning the knob which is supposed to torque limited and the cable snapped.There was no procedural delay.Case was completed using a secondary stabilizer.No reported patient effects.
Additional Manufacturer Narrative
Trackwise # (b)(4) updated section: b4, b5, g4, g7, h2, h3, h6, h10.
Event or Problem Description
The hospital reported that during preparation for a coronary artery bypass procedure, acrobat v stabilizer system internal steel cable snapped.It broke while they were prepping for anastamosis.They were turning the knob which is supposed to torque limited and the cable snapped.There was a procedural delay during procedure.Case was completed using a secondary stabilizer.No reported patient effects.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The hospital reported that during preparation for a coronary artery bypass procedure, acrobat v stabilizer system internal steel cable snapped.It broke while they were prepping for anastamosis.They were turning the knob which is supposed to torque limited and the cable snapped.Physician states that he always goes one click after full tightening.It was feeling loose when it should be tight, vice-versa.No failure occurred after tightened and while device was in use.There was not a struggle to turn the knob.No visual abnormalities with any of the parts in the assembly were noticed.Device visual inspection was fine while it was taken out of the box.There was a procedural delay during procedure.Case was completed using a secondary stabilizer.No reported patient effects.
Additional Manufacturer Narrative
Trackwise#: (b)(4).Corrected sections: d4--catalogue# corrected from "om9000s" to "om-9100s".
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Trackwise#: (b)(4).The device was not returned to maquet cardiac surgery for investigation, therefore no evaluation could be performed.A photograph was provided by the account.A photographic evaluation was conducted.The product information was observed in the photograph.It is not possible to confirm the reported complaint.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.H3 other text : device not returned.

• Brand Name: ACROBAT V 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: 16335233
• Report Number: 2242352-2023-00105
• Device Sequence Number: 17725378
• 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,Followup,Followup
• Report Date (Section B): 06/09/2023

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-9100S
• Device Catalogue Number: OM-9100S
• Device Lot Number: 3000250757
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2023
• Supplement Date Received by Manufacturer: 02/02/2023; 03/02/2023; 04/10/2023; 06/09/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 02/09/2023; 03/21/2023; 04/10/2023; 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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