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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 Device Operates Differently Than Expected (2913); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/05/2018
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 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 was in the tube that was deformed so that it did not slide over the umbrella. The umbrella could thus not be loaded. A replacement device was used to complete the procedure. The hospital did not report any patient effects.
 
Manufacturer Narrative
Updated sections. Corrected section: describe event or problem. Internal complaint number: (b)(4). Autonumber: (b)(4). The device was returned to the factory for evaluation. A visual inspection was conducted. Signs of clinical use with evidence of blood were observed on the plunger and on the side of the loading device. The delivery device was inside the loading device when it was returned. The blue slide lock was engaged and the plunger was not pressed on the delivery device. Upon observation, the seal was visible from the window of the loading device. The delivery device was removed from the loading device for inspection. The seal and the tension spring assembly remained inside the loading device. No deformities were observed on the delivery tube. The tension spring assembly and the seal were then pulled out from the loading device for inspection. Microscopic inspection showed the seal intact, without cracks or delamination. The following measurements of the delivery tube were taken: inner delivery tube diameter was measured at 0. 197 in. , the outer diameter was measured at 0. 219 in. The length of the delivery tube was measured at 2. 48 inches. The measurement values recorded for the delivery tube were within the tolerance specifications. Based upon the received condition of the device, and the results of the evaluation, the reported failure mode "fitting problem" was confirmed.
 
Event Description
The hospital reported that before a coronary artery bypass procedure, hs iii proximal seal system 3. 8mm seal was in the tube that was deformed so that it did not slide over the umbrella. The umbrella could thus not be loaded. 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 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 Key7386850
MDR Text Key104264872
Report Number2242352-2018-00286
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K080169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 03/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/01/2018
Device Catalogue NumberC-HSK-3038
Device Lot Number25132651
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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