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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 Crack (1135); Unraveled Material (1664)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/30/2019
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, hst iii system (3.8mm) threads of the seal were noted to be unraveled just after loading 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) threads of the seal were noted to be unraveled just after loading it.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
H6 correction: device code changed to "crack".Internal complaint number: (b)(4).The device was returned to the factory for evaluation.An investigation was conducted on 01/28/2020.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The delivery device was returned outside the loading device with the white plunge not depressed and the blue slide lock engaged.The seal and tension spring assembly was observed to be inside the delivery tube with the seal outside the delivery tube.No visual defects were observed on the seal or the tension spring assembly.The following measurements of the delivery tube were taken: the inner delivery tube diameter was measured at 0.196 inches, the outer diameter was measured at 0.219 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 " crack" was not confirmed but was confirmed for the analyzed failure "fitting problem".
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm) threads of the seal were noted to be unraveled just after loading it.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
Trackwise # (b)(4).The device was returned to the factory for evaluation.An investigation was conducted on 12/27/2019.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The delivery device was returned outside the loading device with the white plunge not depressed and the blue slide lock engaged.The seal and tension spring assembly was observed to be inside the delivery tube with the seal outside the delivery tube.No visual defects were observed on the seal or the tension spring assembly.Based on the returned condition of the device, the reported failure " unraveled material" was 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 Key9522218
MDR Text Key187261533
Report Number2242352-2019-01426
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,health
Type of Report Initial,Followup,Followup
Report Date 12/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/03/2020
Device Model NumberHST III SYSTEM (3.8MM)
Device Catalogue NumberHSK-3038
Device Lot Number25148318
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2019
Was the Report Sent to FDA? Yes
Date Manufacturer Received01/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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