FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS FUS-120045-P

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-10 for FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS FUS-120045-P manufactured by Cook Inc.

Event Text Entries

[105513134] This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.
Patient Sequence No: 1, Text Type: N, H10


[105513135] It was reported that the guidewire for the flexor parallel ureteral access sheath and dilators kit was caught in the obturator and was found to be? Shredded? After removal. There were no injuries or additional procedures, and no pieces of the device remained in the patient. Also, the wire was significantly stretched and uncoiled, its tip weld had separated, and the inner lining of the sheath was partially scraped off.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2018-01116
MDR Report Key7416450
Date Received2018-04-10
Date of Report2018-04-10
Date of Event2015-12-22
Date Mfgr Received2018-04-09
Device Manufacturer Date2015-08-31
Date Added to Maude2018-04-10
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 Phone8128294891
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameFLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS
Generic NameKOE DILATOR, URETHRAL
Product CodeKOE
Date Received2018-04-10
Catalog NumberFUS-120045-P
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
10 2018-04-10

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