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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); Fitting Problem (2183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/20/2020
Event Type  malfunction  
Manufacturer Narrative
Trackwise id # (b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm) cracked and would not load correctly into the delivery tube.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) cracked and would not load correctly into the delivery tube.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
Trackwise # (b)(4).The lot # 25153237 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 (b)(6) 2021 and investigated on (b)(6) 2021.Signs of clinical use and no evidence of blood were observed.There was no blood in or on the delivery tube.Delivery device was returned outside loading device.The tension spring and seal remained inside the loading device.The white plunger on the delivery device remained not pressed in and the blue lock remained in the locked position.Microscopic inspection showed the tether remained uncut and attached to the seal and tension spring.There was a crack observed at the outer coils of 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 failures "fitting problem" and "crack; seal" were confirmed.
 
Manufacturer Narrative
Corrected section: h3: device not eval provide code: from "other" to "device evaluation anticipated, but not yet begun." trackwise id # (b)(4).
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm) cracked and would not load correctly into the delivery tube.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
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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 Key11031768
MDR Text Key222766611
Report Number2242352-2020-01116
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,health
Type of Report Initial,Followup,Followup
Report Date 12/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/25/2021
Device Model NumberHST III SYSTEM (3.8MM)
Device Catalogue NumberC-HSK-3038
Device Lot Number25153237
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2021
Was the Report Sent to FDA? Yes
Date Manufacturer Received02/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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