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

Model Number HST III SYSTEM (3.8MM)

Device Problem Premature Separation (4045)

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

Event Date 11/04/2021

Event Type  malfunction  

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.

Event Description

The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm) was loaded normally according to the ifu, and the seal was inserted into the aorta hole, but the seal unfolded in the shape of an umbrella.It didn't work and it came out of the hole, so they replaced it with another identical new product and proceeded with surgery.After exchanging the same new product, the operation was completed, and it was confirmed that there was no abnormality in the patient's condition.

Manufacturer Narrative

Trackwise # (b)(4).Analysis of production: (3331/213/67) the device history records review concluded that 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 manufacturing process and the reported failure.Historical data analysis: (4109/213/67) the review of the historical data indicates that no other similar complaints was reported for the same lot number and reported failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period dec 2019 through nov 2021 was reviewed.There were no triggers identified for the review period.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.Testing of actual/suspected device: (10/213/67) the device was returned to the factory for evaluation on 11/15/2021.Photographs were provided by the account.A photographic inspection was conducted.In photograph #1.Signs of clinical use and evidence of blood was observed indicating an attempt was made to introduce the device into the aorta.The delivery device was observed outside the loading device.The seal was observed to be fully deployed inside the delivery device.The aortic cutter was also observed to be fully deployed.A visual inspection was conducted.In photograph #2, the product and lot # was observed on the product packaging box.An investigation was conducted on (b)(6) 2021.Signs of clinical use and heavy amounts of blood was observed on the delivery device as well as on the aortic cutter.The loading device was not returned for evaluation.The seal was observed to be fully deployed inside the delivery tube.The white plunger was fully depressed and the blue slide lock was engaged.The seal and tension spring assembly was removed from the delivery device with no physical or visual difficulties observed.There were no cracks or delamination observed on the seal.No measurements of the delivery tube were taken due to the presence of blood on the delivery device which indicates an attempt was made to introduce the device into the aorta.There were no visual defects observed on the fully deployed aortic cutter.Based on the returned condition of the device, the reported failure "premature activation" was not confirmed.

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: 12845274
• MDR Text Key: 285535365
• Report Number: 2242352-2021-00989
• 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
• Type of Report: Initial,Followup
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2022
• Device Model Number: HST III SYSTEM (3.8MM)
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25158272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 79 KG