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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 Problems Malposition of Device (2616); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/06/2016
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 became entangled in the loader.The seal inside was off from the center.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
Updated: date received by mfr, type of reports, if follow-up, what type?, device evaluated by mfr?, evaluation codes, additional mfr narrative.(b)(4).The device was returned to the factory for evaluation.Signs of clinical use and no evidence of blood were observed.The delivery device was returned inside the loading device.There was no blood in or on the delivery tube.The slide lock was engaged and the plunger was not depressed on the delivery device.The seal and tension spring assembly remained inside the loading device.The seal was wrapped and only about 1/4 of the total length was inside the delivery tube indicating improper loading of the seal.The delivery device was removed from the loading device.The seal completely hung outside the delivery tube with the tension spring assembly, at 3/4 distance of the total length of the delivery tube, inside the tube.The outer edge of the seal was delaminated.The following measurements of the delivery tube were taken : the inner delivery tube diameter was measured at.198 inches , the outer diameter was measured at.220 inches.The length of the delivery tube was measured at 2.49 inches.The values recorded were within the tolerance specifications.Based upon the received condition of the device, the reported complaint was confirmed for reported failure "failure to load" and the analyzed failure "crack seal".Specific actions for the reported failure are being maintained and documented under maquet's corrective and preventive action (capa) system.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal became entangled in the loader.The seal inside was off from the center.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
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Brand Name
HS III PROXIMAL SEAL
Type of Device
CLAMP, 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 Key6074466
MDR Text Key59344182
Report Number2242352-2016-01078
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 foreign,health professional,u
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/15/2017
Device Catalogue NumberC-HS-3045
Device Lot Number25126596
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received12/08/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/15/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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