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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 Component Missing (2306); Detachment of Device or Device Component (2907)
Patient Problem Laceration(s) (1946)
Event Date 04/20/2022
Event Type  Injury  
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.
 
Event Description
The hospital reported that during a coronary artery bypass procedure using hst iii system (3. 8mm). After shooting the delivery system to patient's aorta and removing the seal, (there's no tension or resistance felt, just as usual) they found that the seal was only partially out of the aorta. Part of the seal is still in patient's body. They tried to locate the rest taking to ct but was unable to find it. There was uncertain shadow shown in the ct so patient received angiography the next day. They were able to locate it in the right iliac artery but couldn't remove it. There's no severe adverse event till now, but she's in the icu being monitored. Patient is under crrt in the icu.
 
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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 Key14349326
MDR Text Key291326370
Report Number2242352-2022-00407
Device Sequence Number1
Product Code DXC
UDI-Device Identifier00607567700314
UDI-Public00607567700314
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 Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/19/2022
Device Model NumberHST III SYSTEM (3.8MM)
Device Catalogue NumberHSK-3038
Device Lot Number25160840
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received06/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/19/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/10/2022 Patient Sequence Number: 1
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