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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 Problem Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/27/2017
Event Type  malfunction  
Manufacturer Narrative
Internal complaint number: (b)(4). Autonumber: (b)(4). The device was returned to the factory for evaluation. Signs of clinical use with no evidence of blood were observed. The delivery device was returned outside the loading device. The blue slide lock was engaged and the plunger was not pressed on the delivery device. The tension spring assembly remained inside the delivery device with the seal and part of the tension spring extended hanging beyond the tip of the delivery tube. The tension spring assembly with the seal was removed from the delivery device for inspection. Microscopic inspection showed the seal to be intact, without cracks or delamination. The following measurements of the delivery tube were taken : the inner delivery tube diameter was measured at 0. 197 inches. , the outer diameter was measured at 0. 214 inches. The length of the delivery tube was measured at 2. 500 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 during a coronary artery bypass procedure, hs iii proximal seal system 3. 8mm seal was not able to be inserted within the deployment device completely and as it normally does and came out prior to being inserted into aorta. Device was not used on patient. No patient information available. The issue was noticed during loading. The seal was not able to be inserted. 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 a coronary artery bypass procedure, hs iii proximal seal system 3. 8mm seal was not able to be inserted within the deployment device completely and as it normally does and came out prior to being inserted into aorta. 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 Key7130880
MDR Text Key254435727
Report Number2242352-2017-01174
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,Followup
Report Date 12/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/20/2018
Device Catalogue NumberC-HSK-3038
Device Lot Number25134334
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/19/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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