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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 Positioning Failure (1158)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/29/2018
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, hs iii proximal seal system 4.3mm seal did not deploy.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 and evidence of blood were observed.Blood was observed on the loading device and the delivery device.The delivery device was returned inside the loading device.The blue slide lock was engaged and the plunger was not depressed on the delivery device.The seal and tension spring was in the loading device, with the seal visible in the loading device window.The delivery device was removed from the loading device.The seal and tension spring assembly remained in the loading device.The seal and tension spring was removed from the loading device.A microscopic inspection was conducted.The seal was observed to be cracked on the innermost and outermost coil of the seal.The following measurements of the delivery tube were taken: the inner delivery tube diameter was measured at.197 inches , the outer diameter was measured at.220 inches.The length of the delivery tube was measured at 2.52 inches.The values recorded were within the tolerance specifications.Based upon the received condition of the device, the reported failure "failure to deploy" was not confirmed but was confirmed for the analyzed failures "fitting problem; seal" and "crack seal".
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 4.3mm seal did not deploy.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 and evidence of blood were observed.Blood was observed on the loading device and the delivery device.The delivery device was returned inside the loading device.The blue slide lock was engaged and the plunger was not depressed on the delivery device.The seal and tension spring was in the loading device, with the seal visible in the loading device window.The delivery device was removed from the loading device.The seal and tension spring assembly remained in the loading device.The seal and tension spring was removed from the loading device.A microscopic inspection was conducted.The seal was observed to be cracked on the innermost and outermost coil of the seal.The following measurements of the delivery tube were taken: the inner delivery tube diameter was measured at.197 inches , the outer diameter was measured at.220 inches.The length of the delivery tube was measured at 2.52 inches.The values recorded were within the tolerance specifications.Based upon the received condition of the device, the reported failure "failure to deploy" was not confirmed but was confirmed for the analyzed failures "fitting problem; seal" and "crack seal".
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 4.3mm seal did not deploy.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 4.3MM
Type of Device
CLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
MDR Report Key7631124
MDR Text Key112307912
Report Number2242352-2018-00592
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,health
Type of Report Initial,Followup
Report Date 06/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/15/2018
Device Catalogue NumberC-HSK-3043
Device Lot Number25135557
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2018
Date Manufacturer Received07/06/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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