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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HST III SEAL (3.8MM) CLAMP, VASCULAR

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MAQUET CARDIOVASCULAR LLC HST III SEAL (3.8MM) CLAMP, VASCULAR Back to Search Results
Model Number HST III SEAL (3.8MM)
Device Problem Failure to Unfold or Unwrap (1669)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 05/09/2022
Event Type  Injury  
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.
 
Event Description
Related to (b)(4). Summary: the hospital reported that during a coronary artery bypass procedure, hst iii seal (3. 8mm) hemostasis could not be stopped because clemme did not deploy. The seal did not remain inside the delivery tube. The seal was inserted into the aorta and used as usual. Attempts were made to achieve adequate hemostasis. They had no choice but to clamp to complete the anastomosis. No blood transfusions were required and there was no procedural delay. The product was out of stock and was clamped and operated to complete the procedure. The hospital did not report any patient effects.
 
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Brand NameHST III SEAL (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 Key14593975
MDR Text Key293279301
Report Number2242352-2022-00472
Device Sequence Number1
Product Code DXC
UDI-Device Identifier00607567700314
UDI-Public00607567700314
Combination Product (y/n)N
Reporter Country CodeJA
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/27/2022
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 SEAL (3.8MM)
Device Catalogue NumberHS-3038
Device Lot Number25161829
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/27/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/15/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

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