SWAN-GANZ D97130F5

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-03 for SWAN-GANZ D97130F5 manufactured by Edwards Lifesciences Llc.

Event Text Entries

[177370535] Pacing catheter did not capture. Prior to exchanging device from body, the box and pacer wires were changed. Then after this was exchanged with new catheter and able to continue with case.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9659298
MDR Report Key9659298
Date Received2020-02-03
Date of Report2019-12-19
Date of Event2019-12-18
Report Date2019-12-19
Date Reported to FDA2019-12-19
Date Reported to Mfgr2020-02-03
Date Added to Maude2020-02-03
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSWAN-GANZ
Generic NameCATHETER, FLOW DIRECTED
Product CodeDYG
Date Received2020-02-03
Model NumberD97130F5
Catalog NumberD97130F5
Lot Number62290514
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age0 YR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerEDWARDS LIFESCIENCES LLC
Manufacturer AddressONE EDWARDS WAY IRVINE CA 92614 US 92614


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-03

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