• 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 SeparationProblem (2906)
Patient Problem Failure to Anastomose (1028)
Event Date 03/14/2018
Event Type  Injury  
Manufacturer Narrative
Internal complaint number trackwise # (b)(4). Autonumber # (b)(4). A lot history record review was completed for the reported product lot number. There was no nonconformance recorded in the lot history. The device has been returned to the factory and is being evaluated. A supplemental report will be submitted when the evaluation is completed.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3. 8mm cutter & needle did not deploy completely. As a result partial puncture of aorta wall was present. Aortic cutter was stuck in aortic wall and was pulled out with force. Surgeon decided to apply side-clamp to perform anastomosis.
 
Manufacturer Narrative
Corrected date of birth from 09/12/1989 to 09/17/1989. Internal complaint number: tw (b)(4). Autonumber : # cs-cpl-(b)(4). The hsk iii device was returned to the factory for evaluation. Sign of clinical use and no evidence of blood. A visual inspection was conducted. The aortic cutter was not returned, however, the loading device was returned inside the delivery device. No sign of blood was observed on the device. The slide lock was disengaged but the plunger was not depressed on the delivery device. The delivery device was removed from the loading device. The anchor and tension spring assembly were returned inside the delivery tube, with the seal partially extended outside the tube. The seal and tension spring assembly were removed from the delivery tube. A microscopic inspection determined that the seal was cracked/delaminated at the first outer most coil. No other failures were observed. Based on the condition of the device as found, the reported failure mode ¿failure to fire; cutter; did not fire¿ was not confirmed but confirmed for analyzed failure "crack; seal".
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3. 8mm cutter & needle did not deploy completely. As a result partial puncture of aorta wall was present. Aortic cutter was stuck in aortic wall and was pulled out with force. Surgeon decided to apply side-clamp to perform anastomosis.
 
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 Key7410295
MDR Text Key104802970
Report Number2242352-2018-00321
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,foreig
Type of Report Initial,Followup
Report Date 04/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/12/2018
Device Catalogue NumberC-HSK-3038
Device Lot Number25134175
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/09/2018 Patient Sequence Number: 1
-
-