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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 Failure to Unfold or Unwrap (1669)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/08/2021
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 loaded and deployed properly.When the seal loader was removed, the seal failed to unfold and did not come out from the loader.While pushing the white plunger into the inserted delivery device and removing the delivery device from the aortotomy, the seal was not separated from the delivery device but came out with it.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 loaded and deployed properly.When the seal loader was removed, the seal failed to unfold and did not come out from the loader.While pushing the white plunger into the inserted delivery device and removing the delivery device from the aortotomy, the seal was not separated from the delivery device but came out with it.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 # 25155495 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 02/18/2021.A photograph was provided by the account.A photographic inspection was conducted.Signs of clinical use and evidence of blood was observed on the delivery device as well as on the opened seal.The white plunger is not observed in the photograph.The tension spring assembly was observed inside the delivery tube with the seal in an opened state.An investigation was conducted on 02/26/2021.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the delivery device, the loading device as well as on the seal indicating an attempt was made to introduce the device into the aorta.The seal and tension spring assembly was observed inside the delivery tube with the seal in an open state.The tension spring assembly was observed inside the delivery tube.The seal and tension spring assembly was removed from the delivery tube.No visual defects were observed on the opened seal.No measurements were taken due to the presence of blood.Based on the returned condition of the device, the reported failure "failure to unfold or unwrap" is not 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 Key11375835
MDR Text Key233443703
Report Number2242352-2021-00163
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 02/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/23/2021
Device Model NumberHST III SYSTEM (3.8MM)
Device Catalogue NumberC-HSK-3038
Device Lot Number25155495
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/18/2021
Was the Report Sent to FDA? Yes
Date Manufacturer Received03/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age72 YR
Patient Weight67
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