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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 06/18/2018
Event Type  malfunction  
Manufacturer Narrative
Internal complaint number trackwise # (b)(4). Autonumber # (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 seal didn't deploy properly and it was unable to use. A replacement device was used to complete the procedure. The hospital did not report any patient effects.
 
Manufacturer Narrative
(b)(6). (b)(4). The device was returned to the factory for evaluation. Signs of clinical usage and evidence of blood were observed. The loading device was not returned for investigation. 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. Blood was visible in the delivery device indicating that there was attempt to deploy the device into the aorta. The seal was removed from the delivery tube for evaluation. The seal was observed to be intact with no cracks or delamination. Based on the received condition of the device we were not able to measure the delivery tube dimensions. The reported complaint ¿positioning failure; seal; unable to deploy¿ was not confirmed.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system seal didn¿t deploy properly and it was unable to use. A replacement device was used to complete the procedure. The hospital did not report any patient effects.
 
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Brand NameHS III PROXIMAL SEAL
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
MDR Report Key7679508
MDR Text Key114016918
Report Number2242352-2018-00653
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 07/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Manufacturer06/28/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2018
Is This a Reprocessed and Reused Single-Use Device? No

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