INDY OTW VASCULAR RETRIEVER G51836 INDY-8.0-35-100-40

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 2018-08-03 for INDY OTW VASCULAR RETRIEVER G51836 INDY-8.0-35-100-40 manufactured by Cook Inc.

Event Text Entries

[115969539] Pma/510(k): k160593. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10


[115969540] It was reported the indy otw vascular retriever snare tip broke off during use in the vessel. The tip is currently in the right common iliac artery behind an iliac covered stent. Additional information regarding this event was requested by cook. However, on 08/03/2018, it was stated that due to the policies at the mayo clinic no additional information for this event would be provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2018-02301
MDR Report Key7748217
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2018-08-03
Date of Report2019-02-01
Date of Event2018-07-16
Date Mfgr Received2019-01-02
Device Manufacturer Date2018-03-20
Date Added to Maude2018-08-03
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 ContactMR. LARRY POOL
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal47404
Manufacturer Phone8123392235
Manufacturer G1COOK INC
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal Code47404
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINDY OTW VASCULAR RETRIEVER
Generic NameMMX DEVICE, PERCUTANEOUS RETRIEVAL
Product CodeMMX
Date Received2018-08-03
Returned To Mfg2018-08-03
Model NumberG51836
Catalog NumberINDY-8.0-35-100-40
Lot Number8679701
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-08-03

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