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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 Unraveled Material (1664)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/12/2020
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).After loading the seal, the plunger is separated, but the middle part of the seal is loosened and cannot be used.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 using hst iii system (3.8mm).After loading the seal, the plunger is separated, but the middle part of the seal is loosened and cannot be used.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
Trackwise id # (b)(4).Photographs were provided by the account.The delivery device was outside the loading device with the white plunger not depressed.The blue slide lock is not visible in the photograph that was provided.The seal was observed to be detached from the tension spring assembly in an slightly unraveled state.The aortic cutter was observed to be intact, no visual defects were observed.The device was returned to the factory on 06/18/2020.An investigation was conducted on 06/29/2020.A visual inspection was conducted.There aortic cutter was not returned with the delivery device, loading device and the seal and tension spring assembly.Signs of clinical use and no evidence of blood was observed.The delivery device was returned inside the loading device with the white plunger not depressed and the blue slide lock not dis-engaged.The seal and tension spring assembly was returned outside both loading and delivery devices.The seal was observed to be in unraveled state.The tether and tension spring assembly were detached from the seal but remained intact.The following measurements of the delivery tube were taken: the inner delivery tube diameter was measured at 0.195 inches, the outer diameter was measured at 0.215 inches.The length of the delivery tube was measured at 2.50 inches.The values recorded were within the tolerance specifications.Based on the returned condition of the device, the reported failure "unraveled material" was confirmed.
 
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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 07470
MDR Report Key10210204
MDR Text Key197327449
Report Number2242352-2020-00565
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 06/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/18/2021
Device Model NumberHST III SYSTEM (3.8MM)
Device Catalogue NumberHSK-3038
Device Lot Number25150894
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2020
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 06/29/2020
Initial Date FDA Received06/29/2020
Supplement Dates Manufacturer Received06/29/2020
Supplement Dates FDA Received06/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age87 YR
Patient Weight63
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