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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 Problem Fitting Problem (2183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/30/2020
Event Type  malfunction  
Manufacturer Narrative
Trackwise id # (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 at the delivery device, during the separation, the seal is caught in the middle of the delivery device and does not come off.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm) seal was properly installed in the tube at the delivery device, during the separation, the seal is caught in the middle of the delivery device and does not come off.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
Internal complaint number: (b)(4).The lot # 25153417 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 for evaluation on 04nov2020.Photographs from the account show delivery device was outside loading device.The tension spring and seal remained inside the loading device.The blue slide lock was dis-engaged and the plunger was completely depressed.A cutter with the cap on was shown.The device was investigated on 08jan2021.Signs of clinical use with no evidence of blood were observed.Delivery device was returned inside loading device.The delivery device was removed from the loading device.The tension spring and seal remained inside the loading device.The blue slide lock was dis-engaged and the plunger was completely depressed.The seal was taken out from the loading device for inspection.There was no sign of crack/delamination on the seal.Dimensions of the delivery tube were taken.The inner diameter was measured at 0.197 inches, the outer diameter was measured at 0.220 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 and analyzed failure "premature deployment" has been confirmed.
 
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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 Key10870320
MDR Text Key217980286
Report Number2242352-2020-01026
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 11/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/03/2021
Device Model NumberHST III SYSTEM (3.8MM)
Device Catalogue NumberC-HSK-3038
Device Lot Number25153417
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2020
Was the Report Sent to FDA? Yes
Date Manufacturer Received01/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age61 YR
Patient Weight68
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