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 report with the FDA on 2020-03-17 for ACHIEVE MAPPING CATHETER - 20 MM 990063-020 manufactured by Medtronic Mexico.

Event Text Entries

[183792805] Product event summary: the mapping catheter (b)(4) with lot number 218702917 was returned and analyzed. Visual inspection showed the introducer was removed from the shaft. The (b)(4) tubing was kinked and a twist was reviewed 0. 139 inches and 2. 75 inches from the tip. The identified malfunction was attributed to device use/operational context. In conclusion, the mapping catheter failed the returned product inspection due to the (b)(4) tubing kink and twist. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[183792806] After a completed case, the mapping catheter subsequently tested out of specification per the manufacturer's investigation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9612164-2020-01198
MDR Report Key9843679
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-17
Date of Report2020-03-17
Date of Event2020-02-03
Date Mfgr Received2020-03-10
Device Manufacturer Date2019-10-23
Date Added to Maude2020-03-17
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 Received2020-03-17
Returned To Mfg2020-02-05
Model Number990063-020
Catalog Number990063-020
Lot Number218702917
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC MEXICO
Manufacturer AddressAV. PASEO DEL CUCAPAH #10510 TIJUANA,BC 22570 MX 22570


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-17

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