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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 Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/21/2018
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.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 using hs iii proximal seal system 3.8mm.When device was passed up to the field, the surgeon noticed that it was not loaded properly.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.A visual inspection was conducted.Signs of clinical use with evidence of blood on the loading device were observed.The delivery device was inside the loading device when it was returned.The seal and tension spring assembly was also inside the loading device.It was observed that the blue slide lock was engaged and the white plunger was not pressed on the delivery device.No visual defects were observed.To simulate loading of the seal, a loading procedure was performed following the ifu.The delivery tube was then pulled out of the loading device for inspection.The seal and tension spring assembly appeared to have loaded properly into the tube.The seal and the tension spring assembly were then pulled out from the delivery tube for inspection.The partially rolled up seal appeared intact with no cracks nor delamination.The following measurements of the delivery tube were taken: inner delivery tube diameter was measured at 0.197 in., the outer diameter was measured at 0.218 in.The length of the delivery tube was measured at 2.50 inches.The measurement values recorded for the delivery tube were within the tolerance specifications.Based upon the received condition of the device and the results of the evaluation, the reported failure mode "fitting problem" was not confirmed.
 
Event Description
The hospital reported that during a coronary artery bypass procedure using hs iii proximal seal system 3.8mm.When device was passed up to the field, the surgeon noticed that it was not loaded 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 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 Key7639544
MDR Text Key112551098
Report Number2242352-2018-00596
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 Other
Type of Report Initial,Followup
Report Date 06/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/22/2019
Device Catalogue NumberC-HSK-3038
Device Lot Number25137394
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2018
Is the Reporter a Health Professional? No
Device Age YR
Date Manufacturer Received07/31/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/22/2018
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 Age81 YR
Patient Weight83
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