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

Model Number	ACROBAT SUV STABILIZER SYSTEM
Medical Device Problem Codes	Component Missing (2306); Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id # (b)(6) 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 a coronary artery bypass procedure using acrobat suv stabilizer system, they discovered that one of the blade suture holders has been removed while preparing the chest opener.Prepare a spare blade and check that there are no problems before using it.There is no effect on the patient.
Additional Manufacturer Narrative
Trackwise id # (b)(4).The investigation has been started, since the complaint was received, and the following contents has been conducted: 1.Dhr review: the dhr of the reported lot 3000160873 has been reviewed.No non-conformity is observed indicated the reported failure.All the products had been performed 100% visual inspection during production.They all passed the inspection, which demonstrate that all suture holder is seated completely and correctly inside the cavity and no parts missing 2.Trend review: in the last 12 months, 02nd sep 2020 to 02nd sep 2021, the occurrence rate is approx.0.014%.There¿s no similar complaint reported for this reported lot 3000160873.3.The device was not received, no returned product evaluation could be conducted.From the provided blade photos, which shows the blade missing one suture holder is the right blade, and the second slot missing the suture holder.From the information from the hospital, the suture holder was found not in the blade slot directly when they opening the primary package tray, and they did not remove the suture holder, which demonstrate that the suture holder was not assembed or dropped out after it assembled during production.From the reviewing the incoming inspection records and measuring the relevant dimensions of the blades and the suture holder, there's no non-conformity observed, which demonstrate the relevant dimensions of the blades and suture holders will not cause the suture holder dropped out from the slot.The most probable root cause of missing one surture holder on the blade slot is that, the suture holder was not assembled and not observered during production inspection.
Event or Problem Description
N/a.

• Brand Name: ACROBAT SUV 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: 12526408
• Report Number: 2242352-2021-00766
• Device Sequence Number: 1547849
• Product Code: MWS
• UDI-Device Identifier: 00607567900004
• UDI-Public: 00607567900004
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2021

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: 03/30/2023
• Device Model Number: ACROBAT SUV STABILIZER SYSTEM
• Device Catalogue Number: OM-9000Z
• Device Lot Number: 3000160873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown