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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 Problems Retraction Problem (1536); Activation, Positioning or Separation Problem (2906)
Patient Problem Blood Loss (2597)
Event Date 11/14/2018
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 3.8mm failed to deploy and failed to withdraw the delivery device.The aorta was torn and blood was leaking from the torn aorta.A replacement device was used to complete the procedure.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 3.8mm failed to deploy and failed to withdraw the delivery device.The aorta was torn and blood was leaking from the torn aorta.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).A photographic inspection was conducted.The blue slide lock and plunger could not be seen in the photo.Blood was inside the delivery tube and delivery device.The seal¿s anchor is observed to be in the delivery tube and the seal is completely out in an unraveled state.The tension spring assembly is seen inside the delivery tube detached from the seal.The device was returned to the factory for evaluation.Signs of clinical use was observed.There was blood covering the delivery device.The loading device was not returned.The tension spring assembly remained in the delivery tube with the seal extended outside the tube.The blue slide lock was dis-engaged and the white plunger was fully depressed on the delivery device.Blood was visible in the delivery device indicating that there was attempt to deploy the device into the aorta.The tension spring assembly and the seal were removed from the delivery device when returned.The seal and tension spring assembly were examined.The seal was observed to be completely unraveled, and covered in blood.It appears that the teether was detached from the seal in an uncut state.The dimensions of the delivery tube could not be measured due to the fact that there was blood inside of the tube.Based upon the received condition of the device, and the results of the evaluation, the reported failure "activation problem" is not confirmed, however the analyzed failure "detachment of component; seal" is 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
MDR Report Key8162661
MDR Text Key130310562
Report Number2242352-2018-01278
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
PMA/PMN Number
K130382
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/06/2018
Device Catalogue NumberC-HSK-3038
Device Lot Number25135907
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2018
Device AgeYR
Initial Date Manufacturer Received 12/04/2018
Initial Date FDA Received12/13/2018
Supplement Dates Manufacturer Received03/11/2019
Supplement Dates FDA Received04/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age78 YR
Patient Weight72
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