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U.S. Department of Health and Human Services

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

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MAQUET CARDIOVASCULAR LLC HST III SYSTEM (3.8MM) CLAMP, VASCULAR Back to Search Results
Model Number HST III SYSTEM (3.8MM)
Device Problem Activation Problem (4042)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/02/2020
Event Type  malfunction  
Manufacturer Narrative
Trackwise id# (b)(4). The device has been returned to the factory and is being evaluated. A supplemental report will be submitted when the evaluation is completed.
 
Event Description
The hospital reported that during a coronary artery bypass procedure,hst iii system (3. 8mm) seal failed to deploy. It was loaded properly but it seal was stuck in the delivery device and didn't come out. The procedure was completed with a new device and there was no patient effect reported.
 
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Brand NameHST III SYSTEM (3.8MM)
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 Key11028279
MDR Text Key222065649
Report Number2242352-2020-01129
Device Sequence Number1
Product Code DXC
UDI-Device Identifier00607567700314
UDI-Public00607567700314
Combination Product (y/n)N
Reporter Country CodeKS
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 Date02/19/2021
Device Model NumberHST III SYSTEM (3.8MM)
Device Catalogue NumberC-HSK-3038
Device Lot Number25150363
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received04/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/19/2020
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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