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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HST III SYSTEM (3.8MM); CLAMP, VASCULAR
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MAQUET CARDIOVASCULAR LLC HST 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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/23/2022
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 preparation for a coronary artery bypass procedure using hst iii system (3.8mm).Upon set up of heartstring device, the string did not fold correctly into the tube.The product failed to load correctly, could not be inserted into the deployment tube.A replacement device was used to complete the procedure.There was no harm to the patient.
 
Event Description
The hospital reported that during preparation for a coronary artery bypass procedure using hst iii system (3.8mm).Upon set up of heartstring device, the string did not fold correctly into the tube.The product failed to load correctly, could not be inserted into the deployment tube.A replacement device was used to complete the procedure.There was no harm to the patient, as there was no patient involvement.
 
Manufacturer Narrative
Trackwise#: (b)(4).Corrected section: h6--replaced 2199 with 2645 as there was no patient involvement the device was returned to the factory for evaluation on 05/31/2022.An investigation was conducted on 06/20/2022.A visual inspection was conducted.Signs of clinical use and slight evidence of blood was observed on the loading device.The delivery device was returned inside the loading device with the white plunger not depressed and the blue safety on, which prevents the white plunger from being depressed.The seal was observed in the loading device window.The delivery device was removed from the loading device with no physical or visual difficulties.The seal and tension spring assembly remained inside the loading device.The seal and tension spring assembly was removed from the loading device with no physical or visual difficulties.There were no visual defects, cracks or delamination observed on the seal.Measurements of the delivery device were taken; the inner diameter was measured at 0.196 inches, the outer diameter was measured at 0.218inches (rm2036883).The length of the delivery tube was measured at 2.50 inches (mcv00004217).The measurement values recorded for the delivery tube were within the tolerance specifications.Based on the returned condition of the device, the reported failure "fitting problem" was confirmed.The lot # 25163526 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.
 
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Brand Name
HST III SYSTEM (3.8MM)
Type of Device
CLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ
Manufacturer (Section G)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ
Manufacturer Contact
arelean guzman
45 barbour pond drive
wayne, NJ 
MDR Report Key14685572
MDR Text Key295505440
Report Number2242352-2022-00522
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 Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2023
Device Model NumberHST III SYSTEM (3.8MM)
Device Catalogue NumberC-HSK-3038
Device Lot Number25163526
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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