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

Model Number OM-10000Z

Device Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384)

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

Event Type  malfunction  

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.

Event Description

The hospital reported that during a coronary artery bypass procedure, acrobat-i stabilizer z suture holders on standard blades were not functioning properly and were loose.A new device was opened to complete the procedure.No harm to patient was reported.

Event Description

N/a.

Manufacturer Narrative

Trackwise #(b)(4).Updated sections: b-4, d-9, g-3, g-6, h-2, h-3, h-6, h-10,h11.Corrected section: h6 problem code: changed to 1371.The investigation has been started since the complaint was received, the following contents have been conducted: 1.Dhr review: reported lot # is unknown.A lot history record review was completed for the last lot shipped to the account prior to the event/aware date.There were no ncmrs, rework, or deviations documented for the last lot shipped to the account.Based on the dhr review result, there's no deficiency identified from production relevant to the reported acrobat stabilizer failure prior to this complaint.All the products had been performed and 100% passed visual inspection during production, which demonstrates the suture holders assembled and seated completely and correctly inside the cavity.2.Trend review: for the period 03-feb-2023 to 02-feb-2024, this was the only complaint received in this period for the reported failure mode "suture holder loose¿ and reported device ¿acrobat-i stabilizer om-10000z ".The complaint rate was found to be 0.004% which is under anticipated occurrence rate.3.Returned device evaluation: 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, all suture holders are well seated in blades cavities.A mechanical evaluation was conducted.The device was securely assembled onto a reference retractor.Each of the suture holders were tested using requested sutures following ifu requirement (ifu cv000002817, rev e, page4 warnings and precautions), all the suture holders were seated well, no loose was observed.Based on the returned condition of the device as well as the evaluation results, the reported failure " suture holder loose" was not confirmed.Based upon the above evaluation, it is not possible to determine the root cause or even provide a probable cause since there were no non-conformities discovered for the reported device.The failure mode is addressed in the risk file.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 complaint history review did not identify an adverse trend.There were no consequences or impacts to the patient.No escalation to the capa process is required.No field action is required.

• 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: 18783927
• MDR Text Key: 336262198
• Report Number: 2242352-2024-00144
• Device Sequence Number: 1
• Product Code: MWS
• UDI-Device Identifier: 00607567100008
• UDI-Public: 00607567100008
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/13/2024

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-10000Z
• Device Catalogue Number: OM-10000Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.