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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 Problems Failure to Advance (2524); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/14/2017
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 that during a coronary artery bypass procedure, hs iii proximal seal system 4.3mm once squeezed together and seal was pushed to engage into the clear tube, it bunched up at the bottom and wouldn't fit into the tube.A second one was opened and the same thing happened.They opened a replacement heartstring for the two defective ones.The hospital did not report any patient effects.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 4.3mm once squeezed together and seal was pushed to engage into the clear tube, it bunched up at the bottom and wouldn't fit into the tube.A second one was opened and the same thing happened.They opened a replacement heartstring for the two defective ones.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 blood was observed.The delivery device was returned inside of the loading device.The seal and tension spring assembly remained inside the loading device.The slide lock was dis-engaged.The plunger was not depressed on the delivery device.The seal was taken out from the loading device for inspection.There were cracks and delamination detected on the seal.The following measurements of the delivery tube were taken: the inner delivery tube diameter was measured at.199 in.The outer diameter was measured at.223 in.The length of the delivery tube was measured at 2.51 in.The values recorded were within the tolerance specifications.Based upon the received condition of the device, the reported failure "fitting problem" and the analyzed failure "cracked seal" is confirmed.
 
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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 Key7176466
MDR Text Key96835777
Report Number2242352-2018-00035
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 01/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/20/2018
Device Catalogue NumberC-HSK-3043
Device Lot Number25135033
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2018
Date Manufacturer Received03/12/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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