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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV HS III PROXIMAL SEAL; CLAMP, VASCULAR
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MAQUET CV HS III PROXIMAL SEAL; CLAMP, VASCULAR Back to Search Results
Catalog Number C-HS-3045
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/19/2018
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 preparation for a coronary artery bypass procedure, hs iii proximal seal was not loaded into the delivery system properly.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The hospital reported that during preparation for a coronary artery bypass procedure, hs iii proximal seal was not loaded into the delivery system properly.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
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Brand Name
HS III PROXIMAL SEAL
Type of Device
CLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
MDR Report Key8067084
MDR Text Key127216227
Report Number2242352-2018-01139
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
PMA/PMN Number
K130382
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/19/2018
Device Catalogue NumberC-HS-3045
Device Lot Number25134975
Was Device Available for Evaluation? No
Date Manufacturer Received12/11/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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