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U.S. Department of Health and Human Services

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

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MAQUET CARDIOVASCULAR LLC HSK III SYSTEM (3.8MM); CLAMP, VASCULAR Back to Search Results
Model Number HST III SYSTEM (3.8MM)
Device Problems Unraveled Material (1664); Activation Problem (4042)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/07/2021
Event Type  malfunction  
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
The hospital reported that during a coronary artery bypass procedure using hst iii system (3.8mm).After punching with aortic cutter during off pump cabg, in the process of inserting the delivery system and shooting, the anchor part did not straighten properly, so the seal loosened while adjusting the position, and it was replaced with a new product of the same type.After this, the operation was successfully completed without additional bleeding or adverse reactions in the patient.
 
Event Description
N/a.
 
Manufacturer Narrative
Trackwise # (b)(4).Analysis of production: (3331/213/67) the device history records review concluded that there were 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.Historical data analysis for similar complaints: (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 modes.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period (b)(6) 2019 through (b)(6) 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: (10/213/67) the device was returned to the factory for evaluation on 10/18/2021.A photograph was provided by the account.A photographic inspection was conducted.Signs of clinical use and evidence of blood was observed on the delivery device.The seal was observed to be in an unraveled state out of the device.The white plunger and blue slide lock was not observed in the photograph.The aortic cutter was observed to have blood on it and the device was capped.An investigation was conducted on 10/20/2021.Signs of clinical use and evidence of blood was observed.The delivery device was returned inside the loading device with the white plunger fully depressed and the blue slide lock disengaged.The seal was observed to be an unraveled state outside the delivery device.The tension spring assembly was not returned for evaluation.No measurements of the delivery device were taken due the presence of blood which indicates an attempt was made to introduce the device into the aorta.Based on the photographic inspection as well as the returned condition of the device, the reported failures "activation problem" and "unraveled material" was not confirmed.
 
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Brand Name
HSK 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 Key12707972
MDR Text Key279056744
Report Number2242352-2021-00882
Device Sequence Number1
Product Code DXC
UDI-Device Identifier00607567700314
UDI-Public00607567700314
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K130382
Number of Events Reported1
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 01/06/2022
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
Device Operator Health Professional
Device Expiration Date05/17/2022
Device Model NumberHST III SYSTEM (3.8MM)
Device Catalogue NumberHSK-3038
Device Lot Number25158272
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/18/2021
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/07/2021
Initial Date FDA Received10/27/2021
Supplement Dates Manufacturer Received01/18/2022
Supplement Dates FDA Received01/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/17/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age55 YR
Patient SexMale
Patient Weight75 KG
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