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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 Firing Problem (4011)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/03/2018
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 not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3.8mm seal did not deploy correctly when activated.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 seal did not deploy correctly when activated.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
Corrected: from "positioning failure" to "activation problem" internal complaint number: (b)(4).Autonumber: # (b)(4).The hsk iii device was returned to the factory for evaluation.Signs of clinical use and evidence of blood were observed.A visual evaluation was conducted.The delivery device and seal were returned inside the loading device.The delivery device was removed from inside the loading device.Sign of blood were observed on and inside the delivery device and loading device.Sign of blood was also observed on the seal.The seal was observed to be completely in tact with no signs of crack/delamination.No failures were observed.The blue slide lock was observed to be disengaged 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.Based on the received condition of the device we were not able to measure the delivery tube dimensions.Based upon the received condition of the device, the reported failure ¿activation problem; seal; unable to deploy¿ was unable to be 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 Key7715645
MDR Text Key115063659
Report Number2242352-2018-00713
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 07/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/08/2019
Device Catalogue NumberC-HSK-3038
Device Lot Number25137087
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2018
Device AgeYR
Date Manufacturer Received10/17/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age62 YR
Patient Weight85
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