GLIDESHEATH SLENDER 50-1050

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-31 for GLIDESHEATH SLENDER 50-1050 manufactured by Terumo Medical Corporation.

Event Text Entries

[185722112] The md passed the nitinol guide wire over the needle into the patient's radial artery. When the md pulled the guide wire out, the proximal head of the wire detached, leaving behind some wire and an inner string inside the patient's wrist. The fragment was retrieved and removed. No harm to patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9902670
MDR Report Key9902670
Date Received2020-03-31
Date of Report2020-03-04
Date of Event2020-02-11
Report Date2020-03-04
Date Reported to FDA2020-03-04
Date Reported to Mfgr2020-03-31
Date Added to Maude2020-03-31
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGLIDESHEATH SLENDER
Generic NameINTRODUCER, CATHETER
Product CodeDYB
Date Received2020-03-31
Model Number50-1050
Catalog Number50-1050
Lot NumberXH17
Device AvailabilityY
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerTERUMO MEDICAL CORPORATION
Manufacturer Address950 ELKTON BLVD ELKTON MD 21921 US 21921


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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