ACHIEVE MAPPING CATHETER - 20 MM 990063-020

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-13 for ACHIEVE MAPPING CATHETER - 20 MM 990063-020 manufactured by Medtronic Mexico.

Event Text Entries

[183276390] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[183276391] It was reported that during a cryo ablation procedure, a drop in blood pressure and effusion were noted. As a result of this the procedure was aborted with the patient under general anesthesia. Pericardiocentesis was performed, and blood was removed from the chest and returned to patient. The patient subsequently needed further surgery to repair the injury. Additionally, perforation may have also occurred. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9612164-2020-01163
MDR Report Key9829085
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-13
Date of Report2020-03-13
Date of Event2020-01-29
Date Mfgr Received2020-03-13
Date Added to Maude2020-03-13
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 ContactPAULA BIXBY
Manufacturer Street8200 CORAL SEA ST NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635055378
Manufacturer G1MEDTRONIC MEXICO
Manufacturer StreetAV. PASEO DEL CUCAPAH #10510
Manufacturer CityTIJUANA,BC 22570
Manufacturer CountryMX
Manufacturer Postal Code22570
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameACHIEVE MAPPING CATHETER - 20 MM
Generic NameCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Product CodeDRF
Date Received2020-03-13
Model Number990063-020
Catalog Number990063-020
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC MEXICO
Manufacturer AddressAV. PASEO DEL CUCAPAH #10510 TIJUANA,BC 22570 MX 22570


Patients

Patient NumberTreatmentOutcomeDate
141. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention 2020-03-13

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