OPEN-END FLEXI-TIP URETERAL CATHETER 021304

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 2018-03-06 for OPEN-END FLEXI-TIP URETERAL CATHETER 021304 manufactured by Cook Inc.

Event Text Entries

[101631360] (b)(4). 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


[101631361] It was reported during a cystoscopy retrograde pyelogram procedure while using the open-end flexi-tip ureteral catheter, parts of the catheter sheared off as? Chips?. Some of the chips ended up in the patient? S bladder and were removed successfully with grasping forceps. The karl storz pediatric cystoscope was looked at by the storz representative and they advised that there is a slight bend in the scope and believe this caused the shearing of the catheter. As reported, the product is not available for return and the lot number is not available. No portion of the device remained in the patient? S body. No additional procedures were required due to this occurrence. As reported, there were no adverse effects on the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2018-00593
MDR Report Key7317527
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2018-03-06
Date of Report2018-05-01
Date Mfgr Received2018-04-19
Date Added to Maude2018-03-06
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOPEN-END FLEXI-TIP URETERAL CATHETER
Generic NameGBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
Product CodeGBL
Date Received2018-03-06
Catalog Number021304
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-03-06

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