ARMADA 18 PTA CATHETER 1013470-150

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 2020-03-24 for ARMADA 18 PTA CATHETER 1013470-150 manufactured by Abbott Vascular.

Event Text Entries

[184842689] The device was not returned for analysis. It may be possible that the balloon interacted with anatomy or associated devices causing damage to the outer surface and resulting in balloon rupture; however, this could not be determined. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history did not indicate a lot specific quality issue. The investigation was unable to determine a cause for the reported balloon rupture. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device. The additional armada device referenced is being filed under a separate medwatch report.
Patient Sequence No: 1, Text Type: N, H10


[184842690] It was reported that the procedure was performed to treat a calcified lesion in the mid superficial femoral artery. Two 6x150mm armada 18 balloons ruptured during the first inflation at 8 atmospheres. The procedure was successfully completed with arthrectomy and an additional unspecified balloon catheter. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024168-2020-02843
MDR Report Key9876041
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-24
Date of Report2020-03-24
Date of Event2020-03-02
Date Mfgr Received2020-03-02
Device Manufacturer Date2019-09-25
Date Added to Maude2020-03-24
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 ContactMS. LINDSEY BELL
Manufacturer Street26531 YNEZ RD.
Manufacturer CityTEMECULA CA 925914628
Manufacturer CountryUS
Manufacturer Postal925914628
Manufacturer Phone9519143996
Manufacturer G1ABBOTT VASCULAR, REG # 3005718570 (P099)
Manufacturer StreetCASHEL ROAD
Manufacturer CityCLONMEL TIPPERARY
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARMADA 18 PTA CATHETER
Generic NamePERIPHERAL DILATATION CATHETER
Product CodeLIT
Date Received2020-03-24
Model Number1013470-150
Catalog Number1013470-150
Lot Number9092541
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerABBOTT VASCULAR
Manufacturer Address26531 YNEZ RD. TEMECULA CA 925914628 US 925914628


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.