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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 Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/24/2018
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 preparation for a coronary artery bypass procedure, hs iii proximal seal remained in the loader when the delivery system was pulled out.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Event Description
The hospital reported that during preparation for a coronary artery bypass procedure, hs iii proximal seal remained in the loader when the delivery system was pulled out.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
(b)(4).The device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use and no evidence of blood were observed.The delivery device was returned inside the outside the loading device.The seal and tension spring assembly remained inside the loading device.The blue slide lock on the delivery device was dis-engaged.The white plunger on the delivery device was fully depressed.The seal and tension spring assembly were removed from the loading device for inspection.No visual defects were observed on the seal.The following measurements were taken; the inner delivery tube diameter was measured at.198 in.The outer diameter was measured at.221 in.(rm2036883).The length of the delivery tube was measured at 2.51 in.(mcv00004217).The values recorded were within the tolerance specifications.Based upon the received condition of the device, the reported failure ¿fitting problem¿ was not confirmed but was confirmed for the analyzed failure "premature deployment".
 
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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 Key7575026
MDR Text Key110490229
Report Number2242352-2018-00524
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,distri
Type of Report Initial,Followup
Report Date 06/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/08/2018
Device Catalogue NumberC-HS-3045
Device Lot Number25135949
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2018
Date Manufacturer Received07/16/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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