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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 Positioning Failure (1158)
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.Heavy amounts of blood was observed on the delivery device, as well as inside the delivery tube indicating that there was an attempt to introduce the device into the aorta.The blue slide lock was not engaged and the white plunger was not depressed on the delivery device.The delivery tube was unable to be measured due to the presence of blood in the delivery device.The seal and tension spring was observed to be in the delivery tube.A microscopic inspection was conducted.The seal was observed to be cracked at outer edge but was not delaminated.No other visual defects were observed.Based on the returned condition of the device, the reported failure "fitting problem" was confirmed as well as confirmed for the analyzed failure "crack seal".
 
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 Key8049002
MDR Text Key126514981
Report Number2242352-2018-01115
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,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 an Adverse Event Report? No
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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