IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER ADM04020013P

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 2020-03-23 for IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER ADM04020013P manufactured by Medtronic Ireland.

Event Text Entries

[184431021] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[184431022] Physician intended to use an inpact admiral drug coated balloon during patient treatment. There was no damage noted to packaging prior to use. No issues noted when removing the device from the packaging. The device was inspected without issue. Ifu was followed. Negative prep performed without issue. It is reported a balloon burst occurred. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9612164-2020-01288
MDR Report Key9864655
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-23
Date of Report2020-04-01
Date of Event2020-03-12
Date Mfgr Received2020-03-31
Date Added to Maude2020-03-23
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 ContactTONI O'DOHERTY
Manufacturer StreetPARKMORE BUSINESS PARK WEST
Manufacturer CityGALWAY
Manufacturer Phone091708734
Manufacturer G1MEDTRONIC IRELAND
Manufacturer StreetPARKMORE BUSINESS PARK WEST
Manufacturer CityGALWAY
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER
Generic NameDRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
Product CodeONU
Date Received2020-03-23
Catalog NumberADM04020013P
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC IRELAND
Manufacturer AddressPARKMORE BUSINESS PARK WEST GALWAY


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-23

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