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

Model Number OM-10000

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

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

Event Date 03/09/2024

Event Type  malfunction  

Event Description

The hospital reported that during a coronary artery bypass procedure, acrobat-i stabilizer flexlink arm could not be locked and fixed.Repeated attempts were made, but the cantilever could not be locked and fixed.Therefore, a new cardiac stabilization system (acrobat-i stabilizer) could be locked normally after replacement, and the surgery was successfully completed without any harm to the patient.There was not a procedural delay.

Manufacturer Narrative

E1 event site name exceeded character limitations: (b)(6) hospital.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.

Event Description

On 28-mar 2024, the hospital reported that during a coronary artery bypass procedure, acrobat-i stabilizer cantilever could not be locked.Repeated attempts were made, but the cantilever could not be locked and fixed.Therefore, a new cardiac stabilization system (acrobat-i stabilizer) could be locked normally after replacement, and the surgery was successfully completed without any harm to the patient.

Manufacturer Narrative

Trackwise #(b)(4).Corrected: manufacture site corrected to be suzhou, d4-udi corrected to be suzhou manufactured om-10000; updated: g7-type of the report is "follow up"; h2-follow up report for "additional information"; h6-type of investigation code.The investigation has been started since the complaint was received, the following contents have been conducted: 1.Dhr review: the dhr of the reported lot 3000364157 has been reviewed.No non-conformity relevant with the reported issue is observed.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 can also tighten the flexlink arm.2.Trend review: in the 12 months from event date 09-mar 2023 to 08-mar 2024, the occurrence rate is approx.(b)(4) for suzhou manufactured om-10000/om-10000z.There is no same issue reported for this lot# 3000364157.3.Returned device evaluation: 1).The device was returned to the factory for evaluation on april.15, 2024.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.2).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 could tighten the arm and baffle foot.When the locking lever was locked, the device was able to be locked on the reference retractor.The device was furtherly disassembled for inspection of relevant components which functioned for engagement when knob is rotated.The acme nut is found normal, no damage is indicated; the acme screw exposed threads is within 2-4; the pilot crimping feature and its position is normal.Based on the returned condition of the device as well as the evaluation results, the reported failure "knob difficult/ unable to tighten-arm does not lock" was not confirmed.The root cause could not be determined.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.The device met all product specifications upon leaving the factory.There were no ncrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend.There were no consequences or impacts to the patient.So no fca is needed.The trending will be monitored continuously.

• 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 (SUZHOU) CO.,LTD.; no.158 fang zhou road; suzhou industrial park; suzhou NJ
• Manufacturer Contact: lu helena ; no.158 fang zhou road; suzhou industrial park; suzhou, NJ
• MDR Report Key: 19125999
• MDR Text Key: 340978910
• Report Number: 2242352-2024-00385
• Device Sequence Number: 1
• Product Code: MWS
• UDI-Device Identifier: 00607567700581
• UDI-Public: 00607567700581
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

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
• Device Operator: Health Professional
• Device Model Number: OM-10000
• Device Catalogue Number: OM-10000
• Device Lot Number: 3000364157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/17/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Age: 38 YR
• Patient Sex: Male