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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV HS III PROXIMAL SEAL SYTEM 3.8MM CLAMP, VASCULAR

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MAQUET CV HS III PROXIMAL SEAL SYTEM 3.8MM CLAMP, VASCULAR Back to Search Results
Catalog Number C-HSK-3038
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/17/2018
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. 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, hs iii proximal seal system 3. 8mm seal failed to deploy. A replacement device was used to complete the procedure. The hospital did not report any patient effects.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3. 8mm seal failed to deploy. A replacement device was used to complete the procedure. The hospital did not report any patient effects.
 
Manufacturer Narrative
(b)(4). The device was not returned to maquet cardiac surgery for investigation as it was discarded and an empty box was returned , therefore no evaluation could be performed. It is not possible to confirm the reported complaint " activation problem¿.
 
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Brand NameHS III PROXIMAL SEAL SYTEM 3.8MM
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
MDR Report Key7774510
MDR Text Key117005593
Report Number2242352-2018-00765
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
PMA/PMN Number
K080169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/26/2019
Device Catalogue NumberC-HSK-3038
Device Lot Number25137450
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/01/2018
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received09/25/2018
Is This a Reprocessed and Reused Single-Use Device? No

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