MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC ACCESSRAIL PLATFORM (STANDARD BLADE); INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Model Number	SB-1000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The hospital reported that during preparation for a coronary artery bypass procedure, one of the standard blades would not lock into place.Issue was found before patient was in room.New device and instrument obtained.No delay.
Additional Manufacturer Narrative
Trackwise#: (b)(4).Updated sections: b4, d9, g3, g6, h2, h3, h6, h10.The device was returned to the factory for evaluation on 03/21/2024.An investigation was conducted on 03/26/2024.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed on the returned blade.There were no visual defects observed.A mechanical evaluation was conducted.The returned blade was attached to a reference retractor with no visual or physical difficulties.Based on the returned condition of the device as well as the evaluation results, the reported failure "mechanical problem" was not confirmed.Specific actions for the reported failure mode are being maintained and documented under maquet's corrective and preventive action (capa) system.A lot history record review was completed for lot 3000365546, the only lot shipped to the account in the year prior to the event date.There were no ncmrs, rework, or deviations documented for the last lot shipped to the account.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 or Problem Description
N/a.

• Brand Name: ACCESSRAIL PLATFORM (STANDARD BLADE)
• Common Device Name: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• 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: 18870752
• Report Number: 2242352-2024-00222
• Device Sequence Number: 11505752
• Product Code: DWS
• UDI-Device Identifier: 00607567700215
• UDI-Public: 00607567700215
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2024

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
• Operator of Device: Health Professional
• Device Model Number: SB-1000
• Device Catalogue Number: SB-1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2024
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown