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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 Misfire (2532); Activation, Positioning or Separation Problem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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 misfired.Device was loaded properly, was unlocked, and when plunger was pressed, the seal did not activate.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 misfired.Device was loaded properly, was unlocked, and when plunger was pressed, the seal did not activate.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
Corrected from "kgs" to "lbs" (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 inspection was conducted.The delivery device was returned without 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.The seal and tension spring assembly was removed from the delivery tube.The seal and tension spring assembly was completely intact.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¿ was not 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 Key7871086
MDR Text Key120253570
Report Number2242352-2018-00894
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 09/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/11/2019
Device Catalogue NumberC-HSK-3038
Device Lot Number25139641
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/05/2018
Device AgeYR
Date Manufacturer Received11/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age65 YR
Patient Weight55
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