• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAQUET CV HS III PROXIMAL SEAL CLAMP, VASCULAR Back to Search Results
Catalog Number C-HS-3045
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Code Available (3191)
Event Date 03/07/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). A lot history record review was completed for the reported product lot number. There was no nonconformance recorded in the lot history. 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 preparation for a coronary artery bypass procedure, hs iii proximal seal system did not load into the delivery system properly. Also, the aortic cutter didn¿t work properly. The surgeon finished the surgery without using the devices. The surgeon decided not to use the devices due to the failure on the hs and the ac. He clamped the blood vessel and completed the procedures. The hospital did not report any patient effects.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The hospital reported that during preparation for a coronary artery bypass procedure, hs iii proximal seal system did not load into the delivery system properly. Also, the aortic cutter didn¿t work properly. The surgeon finished the surgery without using the devices. The surgeon decided not to use the devices due to the failure on the hs and the ac. He clamped the blood vessel and completed the procedures. The hospital did not report any patient effects.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHS III PROXIMAL SEAL
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 Key7386767
MDR Text Key104026422
Report Number2242352-2018-00284
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K080169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/26/2018
Device Catalogue NumberC-HS-3045
Device Lot Number25132121
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/26/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/30/2018 Patient Sequence Number: 1
-
-