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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 Failure to Unfold or Unwrap (1669); Fitting Problem (2183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/25/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).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, hst iii system (3.8mm) seal was properly installed in the tube on the delivery device.As the seal did not come off, it could not be used, so the operation was well completed using the same new product, and the patient's condition was not abnormal.The hospital did not report any patient effects.
 
Manufacturer Narrative
Corrected section h6 device code changed to failure to unfold or unwrap.Internal complaint number: (b)(4).The lot # 25152041 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.The device was returned to the factory on 12/02/2020.An investigation was conducted on 12/11/2020.Photographs were provided by the account.A photographic inspection was conducted.The delivery device was observed outside the loading device.The seal and tension spring assembly was observed inside the delivery tube.Slight blood was observed on the outer rim of the seal.The seal was observed to be unraveled at the center of the seal.No other visual defects were observed in the photographs.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the completely unwrapped seal.The delivery device was returned outside the loading device.The seal and tension spring was observed inside the delivery tube.No blood was observed on the delivery device or the loading device.The white plunger was fully depressed on the delivery device and the blue slide lock unlocked.The seal was observed in a deployed state inside the delivery tube.The seal and tension spring assembly was removed from the delivery device.The tether assembly was observed to be detached.The suture string is cut showing clear evidence of clean cut.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 0.219 inches (rm2036883).The length of the delivery tube was measured at 2.49 inches.The values recorded were within the tolerance specifications.Based on the returned condition of the device, the reported failure "failure to unfold or unwrap " was not confirmed but was confirmed for the analyzed failure "premature deployment".
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm) seal was properly installed in the tube on the delivery device.As the seal did not come off, it could not be used, so the operation was well completed using the same new product, and the patient's condition was not abnormal.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 Key11016891
MDR Text Key221761392
Report Number2242352-2020-01104
Device Sequence Number1
Product Code DXC
UDI-Device Identifier00607567700314
UDI-Public00607567700314
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 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/09/2021
Device Model NumberHST III SYSTEM (3.8MM)
Device Catalogue NumberC-HSK-3038
Device Lot Number25152041
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2020
Was the Report Sent to FDA? Yes
Date Manufacturer Received12/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age33 YR
Patient Weight54
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