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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 Problems Mechanical Problem (1384); Premature Activation (1484); Misfire (2532)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/29/2022
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), the aortic cutter is pushed as soon as the safety lock of the heartstring cutter is activated. Attempt made to achieve adequate hemostasis was successful. After that, only aorta cutter used new h/s to finish the operation. There is no unusual event for the patient.
 
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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 Key14521857
MDR Text Key292828963
Report Number2242352-2022-00460
Device Sequence Number1
Product Code DXC
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,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/23/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/27/2022
Is this an Adverse Event Report? No
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? Device Returned to Manufacturer
Date Returned to Manufacturer05/16/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/29/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/09/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

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