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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 Activation, Positioning or SeparationProblem (2906)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2022
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 they loaded the hst iii system (3. 8mm), delivery device according to the ifu during opcab and aorta punched the delivery device using the aortic cutter. Phenomenon occurs. The seal failed to load properly with stuck with delivery device. The blue slide lock was in an unlocked state. The seal had a contact with the patient's aorta. After the seal was loading, press the white plunger, but the seal failed to emerge. The operation was successfully completed by exchanging the product. There was no abnormality in the patient's condition.
 
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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 Key14239334
MDR Text Key290455302
Report Number2242352-2022-00362
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,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/31/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2022
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 Number25162165
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/13/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received05/31/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2022
Is the Device Single Use? Yes
Type of Device Usage Initial

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