TD TORQUE-LINE CATHETER 41239-06

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-25 for TD TORQUE-LINE CATHETER 41239-06 manufactured by Icu Medical, Inc.

Event Text Entries

[134071394] Swan ganz balloon ruptured during procedure - no harm.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8276859
MDR Report Key8276859
Date Received2019-01-25
Date of Report2019-01-18
Date of Event2019-01-15
Report Date2019-01-18
Date Reported to FDA2019-01-18
Date Reported to Mfgr2019-01-25
Date Added to Maude2019-01-25
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
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 TORQUE-LINE CATHETER
Generic NamePROBE, THERMODILUTION
Product CodeKRB
Date Received2019-01-25
Model Number41239-06
Lot Number91-854-SL
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerICU MEDICAL, INC
Manufacturer Address951 CALLE AMANECER SAN CLEMENTE CA 92673 US 92673


Patients

Patient NumberTreatmentOutcomeDate
10 2019-01-25

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