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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV HS III PROXIMAL SEAL SYTEM 4.3MM CLAMP, VASCULAR

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MAQUET CV HS III PROXIMAL SEAL SYTEM 4.3MM CLAMP, VASCULAR Back to Search Results
Catalog Number C-HSK-3043
Device Problem Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/18/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). A lot history record review was completed for the reported product lot number. There were no ncmr¿s for the reported lot number. 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, hs iii proximal seal system 4. 3mm would not load properly. When removing the delivery device, the seal remained in the loader. A replacement device was used to complete the procedure. The hospital did not report any patient effects.
 
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Brand NameHS III PROXIMAL SEAL SYTEM 4.3MM
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
Manufacturer (Section G)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
Manufacturer Contact
45 barbour pond drive
wayne, NJ 07470
MDR Report Key8233918
MDR Text Key132812286
Report Number2242352-2019-00043
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130382
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/02/2019
Device Catalogue NumberC-HSK-3043
Device Lot Number25141934
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received01/31/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/02/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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