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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 Insufficient Information (3190)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 10/24/2021
Event Type  Injury  
Event Description
The hospital reported that during a coronary artery bypass procedure using hst iii seal (4. 5mm). They used it as usual, but they couldn't stop bleeding. They opened a new one and was able to use it. There is no problem with the patient.
 
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.
 
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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 Key12820064
MDR Text Key280818688
Report Number2242352-2021-00960
Device Sequence Number1
Product Code DXC
UDI-Device Identifier00607567700307
UDI-Public00607567700307
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
Type of Report Initial,Followup
Report Date 01/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/21/2022
Device Model NumberHST III SEAL (4.5MM), 5-PACK
Device Catalogue NumberC-HS-3045
Device Lot Number25158948
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/21/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/21/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/16/2021 Patient Sequence Number: 1
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