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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 04/18/2022
Event Type  malfunction  
Event Description
The hospital reported that they abandoned the hst iii system (3. 8mm) because the seal was broken after loading the seal. The procedure was completed without any problems using a spare heartstring. The portion of the seal that remained outside the distal top of the delivery tube was flared more than the direct line of the tube. The seal was not in contact with the patient's aorta. There was no procedural delay and no health hazard to the patient.
 
Manufacturer Narrative
Trackwise id (b)(4).
 
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Brand NameHST III SYSTEM (3.8MM)
Type of DeviceCLAMP, 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 Key14573620
MDR Text Key293159808
Report Number2242352-2022-00466
Device Sequence Number1
Product Code DXC
UDI-Device Identifier00607567700314
UDI-Public00607567700314
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K130382
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHST III SYSTEM (3.8MM)
Device Catalogue NumberHSK-3038
Device Lot Number25162241
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/04/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/21/2022
Is the Device Single Use? Yes
Type of Device Usage Initial

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