Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/01/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).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 3.8mm malfunctioned.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
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.A partial device was returned to the factory for evaluation.The loading device and delivery device was not returned for investigation.The aortic cutter was returned for investigation.A visual inspection was conducted.Signs of blood and clinical use were observed on the aortic cutter.The safety lock of the aortic cutter was disengaged and the actuation button fully depressed inside the tool with the cutter and spiral needled deployed.The needle was not bent.Based on the received condition and evaluation of the device, no malfunctioned was confirmed for the hs iii proximal seal system 3.8mm.
 
Event Description
The hospital reported that during a coronary artery bypass procedure,hs iii proximal seal system 3.8mm malfunctioned.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 Name
HS III PROXIMAL SEAL SYTEM 3.8MM
Type of Device
CLAMP, 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 Key7140134
MDR Text Key95954342
Report Number2242352-2017-01196
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/06/2018
Device Catalogue NumberC-HSK-3038
Device Lot Number25134063
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/25/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/06/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
-
-