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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 Positioning Failure (1158)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/25/2018
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 3.8mm seal failed to deploy.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 failed to deploy.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
(b)(4).Signs of clinical use and evidence of blood were observed.The delivery device was returned outside the loading device.The slide lock on the deliver device was disengaged and the plunger was fully depressed.There was blood on and inside the delivery tube and the delivery device indicating that an attempt was made to deploy the seal.The seal and the tension spring assembly were inside the delivery device with the seal hanging outside the tube and the tension spring assembly inside the tube indicating a successful deployment of the seal.The seal was covered in blood, was circular and intact without any delamination or cracks.The delivery tube could not be measured because of the presence of blood inside it.Based on the return condition of the device and the evaluation results the reported complaint was not confirmed for the reported failure mode " failure to deploy".It was mentioned by the account manager that the users of the device are infrequent users and thus a training was scheduled for the staff and the surgeons to make them comfortable with the ifu.
 
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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 Key7520390
MDR Text Key108671903
Report Number2242352-2018-00471
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 05/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/25/2019
Device Catalogue NumberC-HSK-3038
Device Lot Number25136763
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/03/2018
Initial Date Manufacturer Received 04/26/2018
Initial Date FDA Received05/16/2018
Supplement Dates Manufacturer Received06/12/2018
Supplement Dates FDA Received06/15/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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