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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HST III SEAL (4.5MM), 5-PACK CLAMP, VASCULAR

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MAQUET CARDIOVASCULAR LLC HST III SEAL (4.5MM), 5-PACK CLAMP, VASCULAR Back to Search Results
Model Number HST III SEAL (4.5MM), 5-PACK
Device Problem Activation Problem (4042)
Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/29/2022
Event Type  Injury  
Manufacturer Narrative
Trackwise id (b)(4).
 
Event Description
The hospital reported that during a coronary artery bypass procedure, seal did not fill into the tube of the delivery device. The seal did not load properly. At the setting stage, there was no seal inside the tube. They set it according to the procedure, but could not do it many times, so they rolled the seal by hand and filled it in the tube and tried to deploy it in the aorta, but the seal was caught in the tube and could not be deployed. Therefore, prepare and use an alternative heartstring. There was a delay of a few minutes. There was some increase in bleeding, but no additional blood transfusions were needed. No effect on the patient.
 
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Brand NameHST III SEAL (4.5MM), 5-PACK
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 Key15071025
MDR Text Key296285249
Report Number2242352-2022-00625
Device Sequence Number1
Product Code DXC
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,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/27/2022
Device Model NumberHST III SEAL (4.5MM), 5-PACK
Device Catalogue NumberHS-3045
Device Lot Number25159879
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/30/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/27/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/20/2022 Patient Sequence Number: 1
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