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

Model Number ACROBAT-I STABILIZER

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/20/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).He 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 Description

The hospital reported that during a coronary artery bypass procedure, acrobat-i stabilizer z knob would not tighten.A replacement device was used to complete the procedure.No harm to patient.

Manufacturer Narrative

Trackwise #(b)(4).The investigation has been started since the complaint was received, and the following contents has been conducted: 1.Analysis of production: the dhr of the reported lot 3000295949 has been reviewed.No non-conformity is observed indicated the reported failure.All the products had been performed 100% mechanical function test during production.They all passed the function test, which demonstrate the knob can be tightened and link arm can be tightened.2.Trend analysis: 20 may 2022 to 20 may 2023, the occurrence rate is approx.(b)(4)% which is under anticipated occurrence rate.3.Device was not received for evaluation; the specific root cause for this failure could not be confirmed.4.Review complaint historical data, the failure knob difficult/ unable to tighten-arm does not lock happened before and has been investigated.The most probable root cause for the knob tighten abnormal could be acme nut lead in thread broken for the reason that rotating to lose the knob anti-clockwise rapidly for several circles and then rotating to tighten the knob clockwise rapidly, or rotating the knob leaner or too much strength used, which caused acme screw misaligned with the acme nut lead in thread, acme nut lead in thread broken, then the knob could not be tighten, and link arm could not be tightened.

• Brand Name: ACROBAT-I STABILIZER
• Type of Device: 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: 17125407
• MDR Text Key: 317255409
• Report Number: 2242352-2023-00473
• Device Sequence Number: 1
• Product Code: MWS
• UDI-Device Identifier: 00607567100008
• UDI-Public: 00607567100008
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACROBAT-I STABILIZER
• Device Catalogue Number: OM-10000Z
• Device Lot Number: 3000295949
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/06/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 68 KG