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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 Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/26/2018
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 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 proximal seal dropped inside of the delivery device.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 proximal seal dropped inside of the delivery device.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.The loading device was not returned for evaluation.Signs of clinical usage and slight evidence of blood was observed on the delivery device.The blue slide lock was dis-engaged.The plunger was not depressed on the delivery device.The seal and tension spring assembly were returned in the delivery device in the proper position as per the ifu.The seal was removed from the delivery device and inspected.The seal was observed to be intact with no cracks or delamination.The following measurements were taken; the inner delivery tube diameter was measured as.197 in.The outer diameter was measured at.221 in.The length of the delivery tube was measured at 2.50in.The values recorded were within the tolerance specifications.Based upon the received condition of the device, the reported complaint for "fitting problem" was unable to be confirmed.
 
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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 Key7706050
MDR Text Key114813289
Report Number2242352-2018-00688
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,foreig
Type of Report Initial,Followup
Report Date 07/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2018
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 Manufacturer07/11/2018
Date Manufacturer Received09/10/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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