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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 Crack (1135)
Patient Problem No Information (3190)
Event Date 07/25/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device was returned to maquet for evaluation. Signs of clinical usage and evidence of blood were observed. The delivery device was returned inside the loading device. Blood was observed on the loading device. The delivery device was removed from the loading device. No defects were observed to the loading device and delivery device. The seal and tension spring assembly remained in the delivery tube. The blue slide lock was dis-engaged and the plunger was not depressed. Blood was present in the delivery device, indicating an attempt to deploy the seal in to the aorta. The seal and tension spring assembly were removed for further evaluation. Blood was observed on the seal. The seal was observed to be crack on the outer coil. The tube was unable to be measured due to the presence of blood in the delivery device. Based on the condition of the device as returned, the reported complaint "crack seal" was confirmed.
 
Event Description
The hospital reported that during preparation for a coronary artery bypass procedure, hs iii proximal seal customer found that the edge of the seal was cracked just before loading it into the delivery system. A replacement was used to continue the procedure. The hospital did not report any patient effects.
 
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 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 preparation for a coronary artery bypass procedure, hs iii proximal seal customer found that the edge of the seal was cracked just before loading it into the delivery system. A replacement was used to continue 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
Manufacturer (Section G)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
Manufacturer Contact
45 barbour pond drive
wayne, NJ 07470
MDR Report Key6805727
MDR Text Key246274551
Report Number2242352-2017-00802
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K080169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/01/2018
Device Catalogue NumberC-HS-3045
Device Lot Number25130671
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/14/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/29/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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