TD THERMODILUTION CATHETER 41229-02

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-07 for TD THERMODILUTION CATHETER 41229-02 manufactured by Icu Medical Inc.

Event Text Entries

[138239986] Right heart catheter inserted, when catheter was in pulmonary wedge position user was unable to pull blood from inner lumen. Catheter was removed and noted to have ruptured balloon tip.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5084743
MDR Report Key8403412
Date Received2019-03-07
Date of Report2019-03-05
Date of Event2019-02-05
Date Added to Maude2019-03-08
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTD THERMODILUTION CATHETER
Generic NamePROBE, THERMODILUTION
Product CodeKRB
Date Received2019-03-07
Model Number41229-02
Lot Number90-997-SJ
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerICU MEDICAL INC


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-03-07

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