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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 10/12/2018
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 was dropped into the loader.The delivery system was pulled out and the seal 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 # (b)(4).Autonumber # (b)(4).The device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.Blood was observed on and inside the delivery device, as well as on the seal, indicating an attempt was made to deploy the device into the aorta.The blue slide lock was dis-engaged and the plunger was fully depressed on the delivery device.The seal was returned inside the delivery device.The seal was observed to be intact, no visual defects were observed.The delivery tube was unable to be measured due to the presence of blood in the delivery device.Based on the returned condition of the device, the reported failure "fitting problem" was not confirmed.
 
Event Description
The hospital reported that during preparation for a coronary artery bypass procedure, hs iii proximal seal was dropped into the loader.The delivery system was pulled out and the seal 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 Key8048943
MDR Text Key126657969
Report Number2242352-2018-01113
Device Sequence Number0
Product Code DXC
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 11/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2018
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/16/2019
Device Catalogue NumberC-HS-3045
Device Lot Number25138421
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2018
Date Manufacturer Received03/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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