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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV HS III PROXIMAL SEAL SYTEM 3.8MM CLAMP, VASCULAR

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MAQUET CV HS III PROXIMAL SEAL SYTEM 3.8MM CLAMP, VASCULAR Back to Search Results
Catalog Number C-HSK-3038
Device Problems Improper or Incorrect Procedure or Method (2017); Activation, Positioning or SeparationProblem (2906)
Patient Problem No Information (3190)
Event Date 01/10/2017
Event Type  malfunction  
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. 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. 8 mm seal was loaded correctly, but when surgeon attempted to deploy into the aorta, the seal stayed in the delivery tube. The surgeon suggested it may have been user error. The hospital did not report any patient effects. Related to complaints (b)(4).
 
Manufacturer Narrative
(b)(4). The device was returned to the factory for evaluation. Signs of clinical use and evidence of blood were observed. The delivery device was returned outside the loading device. The seal and tension spring assembly remained in the delivery tube with the seal extended outside the tube. The seal was fully opened. No cracks/delamination was observed on the seal. Blood was visible on the seal. The blue slide lock was did-engaged and the white plunger was fully depressed on the delivery device. Blood was visible in the delivery device indicating that there was attempt to deploy the device into the aorta. Based on the received condition of the device we were not able to measure the delivery tube dimensions. The complaint for the reported failure "failure to deploy" was not confirmed.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3. 8mm seal was loaded correctly, but when surgeon attempted to deploy into the aorta, the seal stayed in the delivery tube. The surgeon suggested it may have been user error. The hospital did not report any patient effects. Related to complaints (b)(4).
 
Manufacturer Narrative
(b)(4). Updated the event description to clarify.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3. 8mm seal was loaded correctly, but when surgeon attempted to deploy into the aorta, the seal stayed in the delivery tube. The surgeon suggested it may have been user error. The hospital did not report any patient effects. Related to complaints (b)(4). Additional information 03/08/2017: there are a total of 5 complaints.
 
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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 Key6305616
MDR Text Key66867945
Report Number2242352-2017-00103
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
Type of Report Initial,Followup,Followup
Report Date 02/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/16/2017
Device Catalogue NumberC-HSK-3038
Device Lot Number25129584
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/16/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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