• 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 Activation, Positioning or Separation Problem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/06/2018
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. 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 deployed incorrectly. A replacement device was used to complete the procedure. The hospital did not report any patient effects.
 
Manufacturer Narrative
(b)(4). Signs of clinical use and evidence of blood were observed. The delivery device was returned outside the loading device. The slide lock on the deliver device was disengaged and the plunger was fully depressed. There was blood on and inside the delivery tube and the delivery device indicating that an attempt was made to deploy the seal. The seal and the tension spring assembly were inside the delivery device with the seal hanging outside the tube and the tension spring assembly inside the tube indicating a successful deployment of the seal. The seal was covered in blood, was circular and intact without any delamination or cracks. The delivery tube could not be measured because of the presence of blood inside it. Based on the return condition of the device and the evaluation results the reported complaint was not confirmed for the reported failure mode "positioning failure".
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3. 8mm deployed incorrectly. 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
MDR Report Key7737298
MDR Text Key115771906
Report Number2242352-2018-00727
Device Sequence Number0
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 07/31/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/31/2018
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/05/2019
Device Catalogue NumberC-HSK-3038
Device Lot Number25136988
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/01/2018
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received10/22/2018
Is This a Reprocessed and Reused Single-Use Device? No

-
-