MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HST III SYSTEM (3.8MM); CLAMP, VASCULAR

Model Number HST III SYSTEM (3.8MM)

Device Problems Failure to Fire (2610); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/13/2022

Event Type  malfunction  

Manufacturer Narrative

Trackwise id (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends.

Event Description

The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm did not fire.Customer opened a new device and it worked as intended.

Manufacturer Narrative

Trackwise id #(b)(4).The device was returned to the factory for evaluation on 06/07/2022.An investigation was conducted on 06/09/2022.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The delivery device was returned inside the loading device with the white plunger not depressed and the blue safety was on, which prevents the white plunger from being depressed.The seal was observed in the loading device window.The delivery device was removed from the loading device with no visual or physical difficulties.The seal and tension spring assembly remained inside the loading device.The seal and tension spring assembly was removed from the loading device with no physical or visual difficulties.There were no cracks or delamination observed on the seal.The aortic cutter was observed to be in a locked state, with the green safety on, which prevents the plunger from being depressed.A mechanical evaluation was conducted.The green safety was engaged and the plunger of the aortic cutter was able to be deploy the cutter.There were no visual defects observed on the cutter.Measurements of the delivery device were taken; the inner diameter was measured at 0.196 inches, the outer diameter was measured at 0.218 inches (rm2036883).The length of the delivery tube was measured at 2.51 inches (mcv00004217).Based on the returned condition of the device, and the evaluation results, no specific failure was reported, however, the analyzed failure "fitting problem" was confirmed.The lot # 25161800 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 unspecified reported failure.

• Brand Name: HST III SYSTEM (3.8MM)
• Type of Device: CLAMP, VASCULAR
• 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: 14459625
• MDR Text Key: 297073502
• Report Number: 2242352-2022-00428
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607567700314
• UDI-Public: 00607567700314
• Combination Product (y/n): N
• PMA/PMN Number: K130382
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2022
• Device Model Number: HST III SYSTEM (3.8MM)
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25161800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1