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U.S. Department of Health and Human Services

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

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MAQUET CARDIOVASCULAR LLC HS III PROXIMAL SEAL SYTEM 3.8MM CLAMP, VASCULAR Back to Search Results
Catalog Number C-HSK-3038
Device Problems Activation, Positioning or SeparationProblem (2906); Activation Problem (4042)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 04/09/2019
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 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 a coronary artery bypass procedure, hs iii proximal seal system 3. 8mm seal would not deploy. A replacement device was used to complete the procedure. The hospital did not report any patient effects.
 
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Brand NameHS III PROXIMAL SEAL SYTEM 3.8MM
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ 07470
Manufacturer (Section G)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ 07470
Manufacturer Contact
45 barbour pond drive
wayne, NJ 07470
MDR Report Key8580891
MDR Text Key144258836
Report Number2242352-2019-00515
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130382
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/05/2020
Device Catalogue NumberC-HSK-3038
Device Lot Number25144483
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/05/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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