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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 Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/15/2020
Event Type  malfunction  
Manufacturer Narrative
Trackwise id# (b)(4). The device has not yet been returned to maquet cardiac surgery for evaluation. We are following up with the customer for the return of the device. A supplemental report will be submitted if the device is received.
 
Event Description
The hospital reported that during a coronary artery bypass procedure using hst iii system (3. 8mm). The cutter was pressed when the aorta cutter cover was removed to use this product (safety lock is also released). It was used as a new product and the surgery was finished, and there is no damage to patient.
 
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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 Key11111069
MDR Text Key225094054
Report Number2242352-2021-00029
Device Sequence Number1
Product Code DXC
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,Followup
Report Date 01/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/15/2021
Device Model NumberHST III SYSTEM (3.8MM)
Device Catalogue NumberC-HSK-3038
Device Lot Number25153605
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2021
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 Manufactured09/15/2020
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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