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 04/22/2022

Event Type  malfunction  

Event Description

Related to (b)(4).The hospital reported that the hst iii system (3.8mm) during opcab based on the ifu, punched it with an aortic cutter and implanted, but the seal came off.The seal failed to load into the aorta properly.The white plunger was pressed.Blood trace was observed.The same new product was used and loaded according to the ifu, but a total of two failed due to the seal coming off again, and a new product was used again.The patient has no harm at all.

Manufacturer Narrative

Trackwise id (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

N/a.

Manufacturer Narrative

Trackwise # (b)(4).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.The device was returned to the factory for evaluation on 04/29/2022.Photographs were provided by the account.A photographic inspection was conducted.Signs of clinical use and evidence of heavy blood was observed on the loading device, the delivery device and seal as well as on the aortic cutter.The seal was observed in the delivery device in a fully deployed state.No cracks or delamination was observed on the seal.Evidence of blood indicates an attempt was made to introduce the device into the aorta.1an investigation was conducted on 05/24/2022.A visual inspection was conducted.The delivery device was returned outside the loading device with the seal and tension spring assembly inside the delivery device.The white plunger was fully depressed and the blue safety was off which allows for the white plunger to be depressed.Signs of clinical use and evidence of heavy blood was observed on the delivery device as well as on the fully deployed seal, indicating that an attempt was made to introduce the device into the aorta.Blood was also observed on the tip of the loading device as well.The seal and tension spring assembly was removed from the delivery device with no physical or visual difficulties observed.There were no visual defects observed on the seal, no cracks or delamination was observed.No measurements of the delivery device were taken due to the presence of blood.Based on the returned condition of the device, as well as the photographic inspection, the reported failure "activation problem" was not confirmed.

• 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: 14459712
• MDR Text Key: 292370961
• Report Number: 2242352-2022-00425
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2022

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: 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: 04/29/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 48 KG