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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 Problem (4042)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/24/2022
Event Type  malfunction  
Manufacturer Narrative
Trackwise id (b)(4). Since the device is not available to be returned to us, a technical evaluation cannot be performed. Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop. Device discarded.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hst iii system (3. 8mm) umbrella cannot be pushed out (failure to deploy). It was not released into the aorta. A replacement device was used to complete the procedure. No harm to 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 Key14594633
MDR Text Key294599993
Report Number2242352-2022-00488
Device Sequence Number1
Product Code DXC
UDI-Device Identifier00607567700314
UDI-Public00607567700314
Combination Product (y/n)N
Reporter Country CodeCH
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 07/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/03/2022
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 Number25162241
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/15/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/21/2022
Is the Device Single Use? Yes
Type of Device Usage Initial

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