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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HST III SYSTEM (4.3MM) CLAMP, VASCULAR

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MAQUET CARDIOVASCULAR LLC HST III SYSTEM (4.3MM) CLAMP, VASCULAR Back to Search Results
Model Number HST III SYSTEM (4.3MM)
Device Problem Crack (1135)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 05/06/2022
Event Type  Injury  
Event Description
The hospital reported that during a coronary artery bypass procedure, hst iii system (4. 3mm) was found that the umbrella had cracks, which could not stop the blood flow. The parachute did not enter the aorta. No extra blood transfusion. No surgical delay. A replacement device was used to complete the procedure. No harm to the patient.
 
Manufacturer Narrative
(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.
 
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Brand NameHST III SYSTEM (4.3MM)
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 Key14594656
MDR Text Key293286486
Report Number2242352-2022-00484
Device Sequence Number1
Product Code DXC
UDI-Device Identifier00607567700321
UDI-Public00607567700321
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 07/28/2022
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 (4.3MM)
Device Catalogue NumberC-HSK-3043
Device Lot Number25162889
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/28/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/22/2022
Is the Device Single Use? Yes
Type of Device Usage Initial

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