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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV HS III PROXIMAL SEAL SYTEM 3.8MM CLAMP, VASCULAR

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MAQUET CV HS III PROXIMAL SEAL SYTEM 3.8MM CLAMP, VASCULAR Back to Search Results
Catalog Number C-HSK-3038
Device Problems Component Falling (1105); Premature Activation (1484)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/03/2017
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 a coronary artery bypass procedure, hs iii proximal seal system 3. 8mm was deployed before it was fired. The seal fell out and a replacement was opened to finish the case. No harm to patient.
 
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Brand NameHS III PROXIMAL SEAL SYTEM 3.8MM
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 Key6981271
MDR Text Key90887725
Report Number2242352-2017-01002
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/18/2018
Device Catalogue NumberC-HSK-3038
Device Lot Number25133759
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received10/05/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/18/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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