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

Model Number OM-9000Z

Device Problems Positioning Failure (1158); Mechanical Problem (1384); Positioning Problem (3009)

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

Event Date 09/06/2023

Event Type  malfunction  

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure, using acrobat suv stabilizer system they turned the handle but could not fix it.No problem using spare.There was no delay.No health hazard to patient.

Manufacturer Narrative

Tw 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.

Manufacturer Narrative

Trackwise#: (b)(4).Updated sections: b4, g4, g7, h2, h3, h6, h10.The device was returned to the factory for evaluation on 09/26/2023.An investigation was conducted on 10/03/2023.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed on the device.There were no visual defects observed on the device.A mechanical evaluation was conducted.The device was securely assembled onto a reference retractor blade by sliding the stabilizer base onto the rail and locking the lever.The knob was evaluated for its ability to tighten the flexlink arm while the locking lever was in both the locked and unlocked positions.The flexlink arm was secured in position when the knob was turned clockwise.The knob did tightened the arm.When the locking lever was locked, the device was able to be locked on the reference retractor.Based on the returned condition of the device as well as the evaluation results, the reported failure "positioning problem" was not confirmed.The lot # 3000288445 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 Description

N/a.

Manufacturer Narrative

Trackwise#: (b)(4).Corrected sections: h6--medical device ¿ problem code corrected from "3009 and 1384" to code "1158".

• Brand Name: ACROBAT SUV 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: 17816451
• MDR Text Key: 324233109
• Report Number: 2242352-2023-00809
• Device Sequence Number: 1
• Product Code: MWS
• UDI-Device Identifier: 00607567900004
• UDI-Public: 00607567900004
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OM-9000Z
• Device Catalogue Number: OM-9000Z
• Device Lot Number: 3000288445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.