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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 Component Falling (1105)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/25/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). A lot history record review was completed for the reported product lot number. There was no nonconformance recorded in the lot history. 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, customer tried to set the hs iii proximal seal according to the procedure. However, the seal dropped in the loader when the delivery system was pulled out and was unable to use. 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, customer tried to set the hs iii proximal seal according to the procedure. However, the seal dropped in the loader when the delivery system was pulled out and was unable to use. A replacement device was used to complete the procedure. The hospital did not report any patient effects.
 
Manufacturer Narrative
Event site state is (b)(6). Internal complaint number: tw# (b)(4). Autonumber: (b)(4). The device was returned to the factory for evaluation. Signs of clinical use with evidence of blood were observed under the wings and at the bottom part of the loading device. The delivery device was outside the loading device when it was returned. The seal and tension spring assembly remained inside the loading device. The blue slider lock on the delivery device was engaged and the white plunger was not pressed. The seal and tension spring assembly were removed from the loading device for inspection. Microscopic inspection determined that the seal was intact with no cracks or delamination. Measurements of the delivery tube were taken. The values recorded were within the tolerance specifications. Based on the returned condition of the device and the results of the investigation, the reported failure mode "fitting problem" was confirmed.
 
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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 Key7291037
MDR Text Key100928420
Report Number2242352-2018-00173
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,distri
Type of Report Initial,Followup
Report Date 02/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/04/2018
Device Catalogue NumberC-HS-3045
Device Lot Number25132269
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/22/2018
Is This a Reprocessed and Reused Single-Use Device? No

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