• 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 SYTEM 3.8MM 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 SYTEM 3.8MM CLAMP, VASCULAR Back to Search Results
Catalog Number C-HSK-3038
Device Problem Device Slipped (1584)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/14/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3. 8mm was used for proximal anastomoses. The umbrella had slipped out of the applicator just before the application after the loading process, carried out by the surgeon, controlled by the surgeon. A second shade was then used. For the second anastomosis the loading procedure was performed by the surgeon himself. The umbrella slipped out of the applicator just before application. Also this anastomosis could be carried out by the use of another umbrella, this time from a 4. 3 system. A replacement device was used to complete the procedure. The hospital did not report any patient effects.
 
Manufacturer Narrative
Internal complaint number trackwise # (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 a coronary artery bypass procedure, hs iii proximal seal system 3. 8mm was used for proximal anastomoses. The umbrella had slipped out of the applicator just before the application after the loading process, carried out by the surgeon, controlled by the surgeon. A second shade was then used. For the second anastomosis the loading procedure was performed by the surgeon himself. The umbrella slipped out of the applicator just before application. Also this anastomosis could be carried out by the use of another umbrella, this time from a 4. 3 system. A replacement device was used to complete the procedure. The hospital did not report any patient effects.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHS III PROXIMAL SEAL SYTEM 3.8MM
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 Key6925908
MDR Text Key248765447
Report Number2242352-2017-00942
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K080169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/24/2018
Device Catalogue NumberC-HSK-3038
Device Lot Number25131549
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received10/26/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/23/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-