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

Model Number	ACROBAT SUV VACUUM STABILIZER SYSTEM, ST
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id# (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure, using acrobat-i stabilizer.They did the positioning and turned the nozzle to fix it, it slipped and could not be fixed.Even after trying several times, it was not fixed in the same way, and finally a substitute was issued and the case was successfully completed.The hospital did not report any patient effects.
Additional Manufacturer Narrative
(b)(4).The lot # 25148602 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, using acrobat-i stabilizer.They did the positioning and turned the nozzle to fix it, it slipped and could not be fixed.Even after trying several times, it was not fixed in the same way, and finally a substitute was issued and the case was successfully completed.The hospital did not report any patient effects.

• Brand Name: ACROBAT SUV VACUUM STABILIZER SYSTEM, ST
• Common Device Name: STABILIZER, HEART
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 10879265
• Report Number: 2242352-2020-01037
• Device Sequence Number: 19472612
• Product Code: MWS
• UDI-Device Identifier: 00607567700543
• UDI-Public: 00607567700543
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2020

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: 10/22/2021
• Device Model Number: ACROBAT SUV VACUUM STABILIZER SYSTEM, ST
• Device Catalogue Number: C-OM-9000S
• Device Lot Number: 25148602
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1