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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV HS III PROXIMAL SEAL SYTEM 4.3MM; CLAMP, VASCULAR
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MAQUET CV HS III PROXIMAL SEAL SYTEM 4.3MM; CLAMP, VASCULAR Back to Search Results
Catalog Number C-HSK-3043
Device Problem Device Difficult to Setup or Prepare (1487)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/18/2018
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 preparation for a coronary artery bypass procedure, hs iii proximal seal system 4.3mm seal did not load properly.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 system 4.3mm seal did not load properly.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 and no evidence of blood were observed.A visual inspection was conducted.The delivery device was returned inside the loading device.The seal could be seen from the loading device window.The delivery device was removed from inside the loading device.The seal and tension spring assembly remained inside the loading device.The slide lock was engaged.The plunger was not depressed on the delivery device.The seal was taken out from the loading device for inspection.No crack/delamination of seal was observed.The following measurements were taken; the inner delivery tube diameter was measured at.197 in.The outer diameter was measured at.221 in.The length of the delivery tube was measured at 2.49 in.The values recorded were within the tolerance specifications.Based upon the received condition of the device, the reported failure mode ¿fitting problem¿ was confirmed.
 
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Brand Name
HS III PROXIMAL SEAL SYTEM 4.3MM
Type of Device
CLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
MDR Report Key8207149
MDR Text Key131904215
Report Number2242352-2018-01384
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,health
Type of Report Initial,Followup
Report Date 12/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/25/2018
Device Catalogue NumberC-HSK-3043
Device Lot Number25135127
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2019
Date Manufacturer Received02/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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