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U.S. Department of Health and Human Services

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

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MAQUET CARDIOVASCULAR LLC HST III SYSTEM (3.8MM) CLAMP, VASCULAR Back to Search Results
Model Number HST III SYSTEM (3.8MM)
Device Problem Mechanical Problem (1384)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 05/09/2022
Event Type  Injury  
Event Description
The hospital reported that during a coronary artery bypass procedure, hst iii system (3. 8mm proximal seal was deployed and installed in the aorta, but the bleeding did not subside. No abnormality was found on the seal when filling. Bleeding subsided when other heartstrings were prepared and used in the same manner. Proceeded with the procedure as it is and finish without any problem. The amount of bleeding increased slightly, but not enough to affect the patient's hemodynamics. The extension of the operation time was about a few minutes. No effect on the patient.
 
Manufacturer Narrative
Trackwise id (b)(4).
 
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Brand NameHST III SYSTEM (3.8MM)
Type of DeviceCLAMP, 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 Key14594626
MDR Text Key293286667
Report Number2242352-2022-00486
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeJA
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 Health Care Professional
Type of Report Initial,Followup
Report Date 07/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHST III SYSTEM (3.8MM)
Device Catalogue NumberC-HSK-3038
Device Lot Number25161182
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/27/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/09/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/03/2022 Patient Sequence Number: 1
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