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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 Problems Crack (1135); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/12/2018
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 cracked and was unable to be loaded into the tube properly when delivery system was pushed into the loading device and pulled out. A replacement device was used to complete the procedure. The hospital did not report any patient effects.
 
Event Description
The hospital reported that during preparation for a coronary artery bypass procedure, hs iii proximal seal cracked and was unable to be loaded into the tube properly when delivery system was pushed into the loading device and pulled out. A replacement device was used to complete the procedure. The hospital did not report any patient effects.
 
Manufacturer Narrative
(b)(4).
 
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Brand NameHS III PROXIMAL SEAL
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
MDR Report Key8048936
MDR Text Key126654479
Report Number2242352-2018-01112
Device Sequence Number0
Product Code DXC
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 11/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/07/2018
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/16/2019
Device Catalogue NumberC-HS-3045
Device Lot Number25138421
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2018
Is This a Reprocessed and Reused Single-Use Device? No

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