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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HST CLAMP, VASCULAR

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MAQUET CARDIOVASCULAR LLC HST CLAMP, VASCULAR Back to Search Results
Model Number HST III SYSTEM (4.3MM)
Device Problems Fitting Problem (2183); Activation Problem (4042)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/18/2022
Event Type  malfunction  
Event Description
The hospital reported that during a coronary artery bypass procedure, hst iii system (4. 3mm) had quality issues. The diameter of the blocking umbrella exceeds the diameter of the delivery pipe after being loaded, resulting in the failure to release normally. A replacement device was used to complete the procedure. No harm to 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. Device discarded.
 
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Brand NameHST
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 Key14594644
MDR Text Key294052275
Report Number2242352-2022-00483
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,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHST III SYSTEM (4.3MM)
Device Catalogue NumberC-HSK-3043
Device Lot Number25161646
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/21/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/06/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

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