ELECTRICAL UMBILICAL CABLE 2035UC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-15 for ELECTRICAL UMBILICAL CABLE 2035UC manufactured by Medtronic Cryocath Lp.

Event Text Entries

[136595969] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[136595970] It was reported that prior to a cryo ablation procedure, the packaging of six electrical umbilical cables were easier to open than normal and the sterility of the cables was questioned. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002648230-2019-00089
MDR Report Key8342598
Date Received2019-02-15
Date of Report2019-03-15
Date of Event2019-01-18
Date Mfgr Received2019-02-19
Device Manufacturer Date2018-09-27
Date Added to Maude2019-02-15
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 ContactLISA ROBERTSON
Manufacturer Street8200 CORAL SEA ST NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635262723
Manufacturer G1MEDTRONIC CRYOCATH LP
Manufacturer Street9000 AUTOROUTE TRANSCANADIENNE
Manufacturer CityPOINTE-CLAIRE,QC H9R 5Z8
Manufacturer CountryCA
Manufacturer Postal CodeH9R 5Z8
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameELECTRICAL UMBILICAL CABLE
Generic NameCABLE
Product CodeISN
Date Received2019-02-15
Returned To Mfg2019-02-01
Model Number2035UC
Catalog Number2035UC
Lot Number33809
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC CRYOCATH LP
Manufacturer Address9000 AUTOROUTE TRANSCANADIENNE POINTE-CLAIRE,QC H9R 5Z8 CA H9R 5Z8


Patients

Patient NumberTreatmentOutcomeDate
10 2019-02-15

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