HST III SYSTEM (3.8MM) HSK-3038

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-11 for HST III SYSTEM (3.8MM) HSK-3038 manufactured by Maquet Cardiovascular Llc.

Event Text Entries

[185712774] 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.
Patient Sequence No: 1, Text Type: N, H10


[185712775] The hospital reported that during a coronary artery bypass procedure using hs iii proximal seal sytem 3. 8mm , after sealing the handle normally,the seal was inserted into the aorta hole, but the seal did not unfold in the shape of an umbrella. A replacement device was used to complete the procedure. The hospital did not report any patient effects.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2242352-2020-00229
MDR Report Key9821863
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2020-03-11
Date of Report2020-03-25
Date of Event2020-02-17
Date Mfgr Received2020-03-18
Device Manufacturer Date2019-07-02
Date Added to Maude2020-03-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street45 BARBOUR POND DRIVE
Manufacturer CityWAYNE NJ 07470
Manufacturer CountryUS
Manufacturer Postal07470
Manufacturer G1MAQUET CARDIOVASCULAR LLC
Manufacturer Street45 BARBOUR POND DRIVE
Manufacturer CityWAYNE NJ 07470
Manufacturer CountryUS
Manufacturer Postal Code07470
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHST III SYSTEM (3.8MM)
Generic NameCLAMP, VASCULAR
Product CodeDXC
Date Received2020-03-11
Returned To Mfg2020-03-02
Model NumberHST III SYSTEM (3.8MM)
Catalog NumberHSK-3038
Lot Number25147144
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMAQUET CARDIOVASCULAR LLC
Manufacturer Address45 BARBOUR POND DRIVE WAYNE NJ 07470 US 07470


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-11

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