MICRO-INTRODUCER KITS H787065072025

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-09-05 for MICRO-INTRODUCER KITS H787065072025 manufactured by Angiodynamics, Inc.

Event Text Entries

[119249456] It was reported that the disposable device was discarded by the user and is not available to be returned to the manufacturer for evaluation. An investigation into the root cause of this incident is currently in progress. The results of the device evaluation will be sent via a follow up medwatch. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[119249457] As reported to angiodynamics on (b)(6) 2018: during a cardiac catheterization procedure, it was noted that a fragment of the guidewire broke off in the patient's right wrist. The fragment was removed under local and site sutured. It was reported the patient suffered no permanent harm or injury due to this event. It was reported the defective disposable device is not available for return to the manufacturer.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1319211-2018-00091
MDR Report Key7847155
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2018-09-05
Date of Report2018-12-20
Date of Event2018-07-31
Date Mfgr Received2018-08-15
Device Manufacturer Date2018-04-07
Date Added to Maude2018-09-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLAW RYAN
Manufacturer Street10 GLENS FALLS TECHNICAL PARK
Manufacturer CityGLENS FALLS NY 12801
Manufacturer CountryUS
Manufacturer Postal12801
Manufacturer Phone5187424488
Manufacturer G1ANGIODYNAMICS, INC
Manufacturer Street603 QUEENSBURY AVENUE
Manufacturer CityQUEENSBURY NY 12804
Manufacturer CountryUS
Manufacturer Postal Code12804
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMICRO-INTRODUCER KITS
Generic NameMICRO-INTRODUCER KITS,
Product CodeDQT
Date Received2018-09-05
Catalog NumberH787065072025
Lot Number5310430
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerANGIODYNAMICS, INC
Manufacturer Address603 QUEENSBURY AVENUE QUEENSBURY NY 12804 US 12804


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-09-05

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