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

Model Number HST III SYSTEM (3.8MM)

Device Problem Activation Problem (4042)

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

Event Date 05/04/2022

Event Type  malfunction  

Event Description

The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm) was loaded according to the ifu during opcab and punched it with an aortic cutter and then implanted, but the seal did not come out of the delivery device handle.The white plunger was pressed.The blue slide lock was in an unlock state.The surgery was successfully completed using the same new product.There was no abnormality in the patient's condition.

Manufacturer Narrative

(b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.

Manufacturer Narrative

Trackwise#: (b)(4).The device was returned to the factory for evaluation on 05/16/2022.Photographs were provided by the account.A photographic inspection was conducted.Signs of clinical use and evidence of blood was observed on the delivery device which indicates an attempt was made to introduce the device into the aorta.The seal was observed in a deployed open state in the delivery device.The white plunger was observed in the photograph depressed and the blue safety off which allows for the white plunger to be depressed.There were no visual defects observed on the seal or the loading device.An investigation was conducted on 06/01/2022.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the delivery device as well as on the fully opened deployed seal.The delivery device was returned outside the loading device with seal inside the delivery device.The seal and tension spring assembly was removed from the delivery device with no visual or physical difficulties.There were no cracks or delamination observed on the seal.No measurements of the delivery device were taken due to the presence of blood which indicates an attempt was made to introduce the device into the aorta.Based on the photographic inspection, and the evaluation results, the reported failure "activation problem" was not confirmed.The lot # 25162165 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.

• 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: 14519892
• MDR Text Key: 292830334
• Report Number: 2242352-2022-00458
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607567700314
• UDI-Public: 00607567700314
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K130382
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2023
• Device Model Number: HST III SYSTEM (3.8MM)
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25162165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1