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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV HS III PROXIMAL SEAL SYTEM 4.3MM CLAMP, VASCULAR

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MAQUET CV HS III PROXIMAL SEAL SYTEM 4.3MM CLAMP, VASCULAR Back to Search Results
Catalog Number C-HSK-3043
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/21/2018
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. 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 4. 3mm was being used accordingly to the ifu in order to load the proximal seal into the delivery system. After using the aortic cutting instrument, insertion of the delivery device tip into the aortotomy site and actuation of the plunger, the seal did not properly deploy. The surgeon sealed with his finger, waiting for a new heartstring iii to be ready for use. Then the new heartstring iii was used in order to perform the anastomosis. The hospital did not report any patient effects.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 4. 3mm was being used accordingly to the ifu in order to load the proximal seal into the delivery system. After using the aortic cutting instrument, insertion of the delivery device tip into the aortotomy site and actuation of the plunger, the seal did not properly deploy. The surgeon sealed with his finger, waiting for a new heartstring iii to be ready for use. Then the new heartstring iii was used in order to perform the anastomosis. The hospital did not report any patient effects.
 
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Brand NameHS III PROXIMAL SEAL SYTEM 4.3MM
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 Key7687819
MDR Text Key114329785
Report Number2242352-2018-00675
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeFR
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 07/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/23/2018
Device Catalogue NumberC-HSK-3043
Device Lot Number25133060
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/23/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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