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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 Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/18/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).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 a incident occurred with the heartstring device when doctor tried to use device it didn't work.Device was checked and the white round patch inside looks weird and stuck inside.A replacement device was used to complete the procedure.
 
Manufacturer Narrative
(b)(4).A lot history record review was completed for lots 25125745 and 25129321.The last 2 lots shipped to the account prior to the event date.There was no nonconformance which could be considered related to the reported event recorded in the lot history.The device was returned to the factory for evaluation.Signs of clinical use and evidence of blood were observed.Traces of blood were observed on the loading device.The delivery device was returned outside the loading device.The seal and tension spring assembly was returned separately outside the loading device.The slide lock was engaged.The plunger was not depressed on the delivery device.No crack/delamination of seal was observed.The following measurements were taken; the inner delivery tube diameter was measured at.198 in.The outer diameter was measured at.220 in.The length of the delivery tube was measured at 2.49 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 confirmed.
 
Event Description
The hospital reported a incident occurred with the heartstring device when doctor tried to use device it didn't work.Device was checked and the white round patch inside looks weird and stuck inside.A replacement device was used to complete the procedure.Additional information 1/31/2017- we just open the package and handed it to dr.(b)(6) but when he's about to use it, it doesn't work.We checked it and the white round patch inside looks weird and stuck inside.We really don't know why it's not working.When we open the second package everything is great! ".
 
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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 Key6330745
MDR Text Key67656540
Report Number2242352-2017-00140
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 02/14/2017
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 Catalogue NumberC-HSK-3043
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/02/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/18/2017
Initial Date FDA Received02/14/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/07/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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