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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 Problem Component Falling (1105)
Patient Problem No Information (3190)
Event Date 09/05/2016
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 3.8mm dropped from delivery device.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
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.Blood was visible on the loading device.The seal and tension spring assembly were not returned.The device as returned was unable to be evaluated for position of seal and tension spring assembly.The slide lock was engaged.The plunger was not depressed on the delivery device.The following measurements were taken; the inner delivery tube diameter was measured at.197 in.The outer diameter was measured at.221 in.The length of the delivery tube was measured at 2.50 in.The values recorded were within the tolerance specifications.Based upon the received condition of the device, the reported complaint for failure to load was not confirmed.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3.8mm dropped from delivery device.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 3.8MM
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 Key5998315
MDR Text Key56596733
Report Number2242352-2016-00956
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
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
Report Date 09/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/14/2016
Device Catalogue NumberC-HSK-3038
Device Lot Number25119757
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2016
Is the Reporter a Health Professional? Yes
Device AgeYR
Date Manufacturer Received11/02/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/14/2015
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 Age54 YR
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