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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 Component Falling (1105); Activation, Positioning or Separation Problem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/22/2016
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.A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3.8mm fell out of the aorta and deployed.A replacement device was used to complete the procedure.The hospital did not report any patient effects.The product is returning.
 
Manufacturer Narrative
(b)(4).The device was returned to the factory for evaluation.It showed signs of clinical usage and evidence of blood.The delivery device was returned outside the loading device.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 and on the delivery device, loading device indicating that there was attempt to deploy the device into the aorta.Blood was found on the seal.Based on the received condition of the device we were not able to measure the delivery tube dimensions.The reported complaint ¿premature deployment¿ was not confirmed.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3.8mm fell out of the aorta and deployed.A replacement device was used to complete the procedure.The hospital did not report any patient effects.The product is returning.
 
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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
Manufacturer (Section G)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
Manufacturer Contact
45 barbour pond drive
wayne, NJ 07470
MDR Report Key5877210
MDR Text Key52753077
Report Number2242352-2016-00760
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/20/2017
Device Catalogue NumberC-HSK-3038
Device Lot Number25125990
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/08/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/07/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/20/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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