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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV HS III PROXIMAL SEAL; CLAMP, VASCULAR
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MAQUET CV HS III PROXIMAL SEAL; CLAMP, VASCULAR Back to Search Results
Catalog Number C-HS-3045
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/18/2018
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 didn't deploy properly and was unable to be used.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).The device was returned to the factory for evaluation.Signs of clinical use was and evidence of blood was observed.The delivery device was returned outside of the loading device.The delivery device was covered in blood.The blue slide lock was disengaged and the plunger fully pressed.The tension spring assembly remained in the delivery tube with the seal extended outside the tube.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 then pulled out from the delivery tube for inspection.The seal was covered in blood.There were no cracks and/or delamination present on the seal.Due to the returned condition of the delivery device in regard to the amount of blood present, the measurements of the delivery tube could not be conducted.Based upon the received condition of the device, and the results of the evaluation, the reported failure "activation problem" is not confirmed.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal didn't deploy properly and was unable to be used.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
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Brand Name
HS III PROXIMAL SEAL
Type of Device
CLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
MDR Report Key8237778
MDR Text Key132784761
Report Number2242352-2019-00050
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 01/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/18/2019
Device Catalogue NumberC-HS-3045
Device Lot Number25140382
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/07/2019
Date Manufacturer Received02/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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