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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HST III SYSTEM (4.3MM) CLAMP, VASCULAR

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MAQUET CARDIOVASCULAR LLC HST III SYSTEM (4.3MM) CLAMP, VASCULAR Back to Search Results
Model Number HST III SYSTEM (4.3MM)
Device Problem Activation Problem (4042)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/29/2020
Event Type  malfunction  
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
The hospital reported that during a coronary artery bypass procedure, hst iii system (4. 3mm) blocking device cannot be released normally. (device cannot be deployed) a replacement device was used to complete the procedure. The hospital did not report any patient effects.
 
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Brand NameHST III SYSTEM (4.3MM)
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ 07470
Manufacturer (Section G)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ 07470
Manufacturer Contact
dorota wolpiuk
45 barbour pond drive
wayne, NJ 07470
MDR Report Key11031668
MDR Text Key222772533
Report Number2242352-2020-01137
Device Sequence Number1
Product Code DXC
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/08/2021
Device Model NumberHST III SYSTEM (4.3MM)
Device Catalogue NumberC-HSK-3043
Device Lot Number25151996
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received05/06/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/05/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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