ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET PT-65509

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-03 for ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET PT-65509 manufactured by Arrow International Inc..

Event Text Entries

[181829615] (b)(4). Additional information received from sales rep. The user was not concerned about the tip migrating.
Patient Sequence No: 1, Text Type: N, H10


[181829616] The customer reports: tip came off during use. Could not remove with snare. Used a different ptd in to loosen and they couldn't because it was embedded into the tissue. Then they put a stent over the tip. The reported defect was detected during use. The patient condition is reported as "fine". There was no patient complication, injury or consequence.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9680794-2020-00125
MDR Report Key9781278
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-03-03
Date of Report2020-02-21
Date of Event2020-02-20
Date Mfgr Received2020-04-03
Device Manufacturer Date2019-11-13
Date Added to Maude2020-03-03
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 ContactKATHARINE TARPLEY
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194334854
Manufacturer G1ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.
Manufacturer StreetAVE. WASHINGTON 3701 COLONIA PANAMERICANA, CHIHUAHUA
Manufacturer CityCHIHUAHUA 31200
Manufacturer CountryMX
Manufacturer Postal Code31200
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET
Generic NameCATHETER EMBOLECTOMY
Product CodeDXE
Date Received2020-03-03
Returned To Mfg2020-03-16
Catalog NumberPT-65509
Lot Number13F19L0282
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerARROW INTERNATIONAL INC.
Manufacturer AddressREADING PA


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-03

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