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

Model Number	ACROBAT V STABILIZER SYSTEM
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 an opcab procedure using acrobat v stabilizer system, they were removing suture in the blade suture stays, when one of the black rubber stays became detached.The black rubber suture did become detached inside the patient.An attempt was made to retrieve the black suture stay.They were not able to locate.They can not confirm where the suture stay currently is.Procedure completed with same device.No procedural delays reported.No additional incisions were reported.No known adverse outcomes.
Additional Manufacturer Narrative
Trackwise # (b)(4).Corrected section: h6-health effect ¿ impact codes - "surgical intervention|device revision or replacement"- not needed, no replacement used.Analysis of production: (3331/213/67) the device history records review concluded that 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 manufacturing process and the reported failure mode.Historical data analysis: (4109/213/67) the review of the historical data indicates that no other similar complaints was reported for the same lot number and reported failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period oct 2019 through sept 2021 was reviewed.There were no triggers identified for the review period.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.Testing of actual/suspected device : (10 /13 & 22) enter investigation findings: the device was returned to the factory for evaluation on 09/30/2021.An investigation was conducted on 10/13/2021.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.Only one (01) black rubber stays was observed detached from the blade.There were no other visual defects observed.Based on the returned condition of the device, the reported failure "detachment of device or device component" was confirmed.The dhr, shop floor paperwork was reviewed.The vendor certifies that this device serial/lot conforms to all applicable product specifications.The dhr, shop floor paperwork is available for review as an attachment to the record.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Trackwise # (b)(4).
Event or Problem Description
The hospital reported that during an opcab procedure using acrobat v stabilizer system, they were removing suture in the blade suture stays, when one of the black rubber stays became detached.The black rubber suture did become detached inside the patient.The suture stop component that had displaced, was located before they closed the patient¿s chest and was not left in the chest as we believed and is currently noted in the product complaint.Procedure completed with same device.No procedural delays reported.No additional incisions were reported.No known adverse outcomes.

• Brand Name: ACROBAT V STABILIZER SYSTEM
• 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: 12643622
• Report Number: 2242352-2021-00837
• Device Sequence Number: 4379868
• Product Code: MWS
• UDI-Device Identifier: 00607567700536
• UDI-Public: 00607567700536
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/14/2022
• Device Model Number: ACROBAT V STABILIZER SYSTEM
• Device Catalogue Number: OM-9100S
• Device Lot Number: 25158772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 12/09/2021; 01/16/2022
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 12/10/2021; 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown