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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 Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 05/11/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device was returned to the factory for evaluation. Signs of clinical use and evidence of blood were observed. The delivery device was returned outside the loading device. The seal and tension spring assembly remained inside the loading device. The tension spring assembly and the seal were removed from the loading device for observation. The seal was observed to be intact with no cracks or delamination. The slide lock was engaged. The plunger was not depressed on the delivery device. Based upon the received condition of the device, based upon the received condition of the device, the reported complaint for ¿fitting problem¿ was confirmed. (b)(4).
 
Event Description
The hospital reported that during preparation for a coronary artery bypass procedure, hs iii proximal seal remained in the loader when the delivery system was pulled out. A replacement device was used to complete 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 remained in the loader when the delivery system was pulled out. 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
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 Key6631850
MDR Text Key192362758
Report Number2242352-2017-00567
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,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2017
Device Catalogue NumberC-HS-3045
Device Lot Number25129543
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/14/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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