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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HSK III SYSTEM (3.8MM); CLAMP, VASCULAR
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MAQUET CARDIOVASCULAR LLC HSK III SYSTEM (3.8MM); CLAMP, VASCULAR Back to Search Results
Model Number HST III SYSTEM (3.8MM)
Device Problems Filling Problem (1233); Fitting Problem (2183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/06/2020
Event Type  malfunction  
Manufacturer Narrative
Trackwise id # (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 using hst iii system (3.8mm) , they stated that seal is caught in the middle part of delivery device in the process of separating after checking in seal loader window that seal is properly installed in tube at delivery device.I tried to remove the seal forcibly but i couldn't use it because the seal didn't come off.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
Corrected section: h6 device code - changed to fitting problem.Trackwise # (b)(4).The device was returned to the factory for evaluation on 12mar2020 and investigated on 22apr2020.A photographic evaluation was conducted.No sign of blood was observed.Only the seal was observed in the body of the loading device.Signs of clinical use and no evidence of blood were observed.There was no blood in or on the delivery tube.Delivery device was returned outside loading device.The tension spring and seal remained inside the body of the loading device, outside the loading window.The blue slide lock was dis-engaged and the plunger was completely depressed.The seal was then pulled out from the loading device for inspection.Microscopic inspection showed the tether remained uncut and attached to the seal and tension spring.No crack/delamination of seal was observed.Dimensions of the delivery tube were taken.The inner diameter was measured at 0.197 inches, the outer diameter was measured at 0.219 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 on the returned condition of the device and evaluation results, the reported failure "fitting problem" was confirmed.
 
Event Description
The hospital reported that during a coronary artery bypass procedure using hst iii system (3.8mm) , they stated that seal is caught in the middle part of delivery device in the process of separating after checking in seal loader window that seal is properly installed in tube at delivery device.I tried to remove the seal forcibly but i couldn't use it because the seal didn't come off.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
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Brand Name
HSK III SYSTEM (3.8MM)
Type of Device
CLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ 07470
MDR Report Key9888004
MDR Text Key185285815
Report Number2242352-2020-00315
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
PMA/PMN Number
K130382
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/08/2020
Device Model NumberHST III SYSTEM (3.8MM)
Device Catalogue NumberHSK-3038
Device Lot Number25149291
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2020
Was the Report Sent to FDA? Yes
Date Manufacturer Received04/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age71 YR
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