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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 Positioning Failure (1158)
Patient Problem No Information (3190)
Event Date 10/09/2017
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.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 seal failed to deploy properly.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
Trackwise number # (b)(4).Autonumber # (b)(4).
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 4.3mm seal failed to deploy properly.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
Internal complaint number trackwise # (b)(4).Autonumber # (b)(4).
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 4.3mm seal failed to deploy 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 SYTEM 4.3MM
Type of Device
CLAMP, 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 Key6992971
MDR Text Key91232078
Report Number2242352-2017-01017
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K080169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 10/31/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/20/2018
Device Catalogue NumberC-HSK-3043
Device Lot Number25132998
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device Age YR
Initial Date Manufacturer Received 10/09/2017
Initial Date FDA Received11/01/2017
Supplement Dates Manufacturer Received12/12/2017
01/18/2018
Supplement Dates FDA Received12/15/2017
01/18/2018
Date Device Manufactured06/20/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age59 YR
Patient Weight70
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