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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 Problems Improper or Incorrect Procedure or Method (2017); Failure to Fire (2610)
Patient Problem Injury (2348)
Event Date 05/08/2018
Event Type  malfunction  
Manufacturer Narrative
(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, hs iii proximal seal system 3. 8mm punch did not fire as expected by the surgeon. With further discussions, it appears there was miscommunication between the surgeon and staff. The safety was still 'on' and that was the issue. There was an unexpected injury to the tissue at the anastomotic site. The surgeon repaired the injury at the anastomotic site and completed the procedure.
 
Manufacturer Narrative
(b)(4). A lot history record review was completed for lot numbers 25135290, 25136275, and 25136763 the last 3 lots shipped to the account prior to the event date. There are no ncmr¿s which could be considered related to the reported event recorded in the lot history.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3. 8mm punch did not fire as expected by the surgeon. With further discussions, it appears there was miscommunication between the surgeon and staff. The safety was still 'on' and that was the issue. There was an unexpected injury to the tissue at the anastomotic site. The surgeon repaired the injury at the anastomotic site and completed the procedure.
 
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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 Key7574953
MDR Text Key110273141
Report Number2242352-2018-00523
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 06/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberC-HSK-3038
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/06/2018 Patient Sequence Number: 1
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