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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 Failure to Fold (1255)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/21/2017
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.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 3.8 mm failed to load due to seal not folding 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.Signs of clinical use with evidence of blood were observed.The delivery device was returned inside the loading device.Traces of blood were observed on the loading device.The blue slide lock was engaged and the plunger was not pressed on the delivery device.The seal and tension spring assembly remained inside the loading device.It was observed that the seal was visible through the window of the loading device and appeared unraveled.The delivery device was removed from the loading device.The tension spring assembly with the seal was removed from the delivery device for inspection.Microscopic inspection showed the seal to be partially unraveled.The following measurements of the delivery tube were taken : the inner delivery tube diameter was measured at 0.197 inches., the outer diameter was measured at 0.228 inches.The length of the delivery tube was measured at 2.503 inches.The values recorded 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 confirmed.The analyzed failure mode "unraveled seal" was also confirmed.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3.8 mm failed to load due to seal not folding properly.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
Internal complaint number: (b)(4).Autonumber: (b)(4).The device was returned to the factory for evaluation.Signs of clinical use with evidence of blood were observed.The delivery device was returned inside the loading device.Traces of blood were observed on the loading device.The blue slide lock was engaged and the plunger was not pressed on the delivery device.The seal and tension spring assembly remained inside the loading device.It was observed that the seal was visible through the window of the loading device and appeared unraveled.The delivery device was removed from the loading device.The tension spring assembly with the seal was removed from the delivery device for inspection.Microscopic inspection showed the seal to be partially unraveled.The following measurements of the delivery tube were taken : the inner delivery tube diameter was measured at 0.197 inches., the outer diameter was measured at 0.228 inches (b)(4).The length of the delivery tube was measured at 2.503 inches (b)(4).The values recorded were within the tolerance specifications.Based upon the received condition of the device, the photos received from the complainant, and the results of the evaluation, the reported failure mode "fitting problem" was confirmed.The analyzed failure mode "unraveled seal" was also confirmed.
 
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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 Key7124500
MDR Text Key95393378
Report Number2242352-2017-01166
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 Other
Type of Report Initial,Followup,Followup
Report Date 12/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/05/2017
Device Catalogue NumberC-HSK-3038
Device Lot Number25129882
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2017
Is the Reporter a Health Professional? No
Device Age YR
Date Manufacturer Received02/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/04/2016
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 Age71 YR
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