UNIVERSA LOOP NEPHROSTOMY PERCUTANEOUS DRAINAGE CATHETER G55804 ULCS-14-30

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other,use report with the FDA on 2019-05-21 for UNIVERSA LOOP NEPHROSTOMY PERCUTANEOUS DRAINAGE CATHETER G55804 ULCS-14-30 manufactured by Cook Inc.

Event Text Entries

[146369811] (b)(6). Pma/510k #: k140085. 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


[146369812] It is reported during a procedure to place a "percutaneous drain of the abdomen with the use of a nephrostomy set" using a universa loop nephrostomy percutaneous drainage catheter, "the guide wire was faulty. " "the guide wire was inserted into the abdomen, dilators were then used and once the pigtail was inserted, the guide wire was then pulled back and during that process that is when we realized it was untangling. " it was not possible to insert the guide wire into the abdomen again. "everything else in the nephrostomy set was alright, however the guide wire was faulty" it is not known how the procedure was completed after the difficulty. There were no adverse effects to the patient as a result of this alleged product malfunction. The patient did not require any additional procedures as a result of this occurrence. Additional details regarding the patient and the event have been requested. At this time, no additional information has been provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2019-01169
MDR Report Key8629107
Report SourceDISTRIBUTOR,FOREIGN,OTHER,USE
Date Received2019-05-21
Date of Report2019-07-30
Date of Event2019-04-24
Date Mfgr Received2019-07-04
Device Manufacturer Date2018-10-25
Date Added to Maude2019-05-21
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 NameUNIVERSA LOOP NEPHROSTOMY PERCUTANEOUS DRAINAGE CATHETER
Generic NameKOB CATHETER, SUPRAPUBIC (AND ACCESSORIES)
Product CodeKOB
Date Received2019-05-21
Returned To Mfg2019-06-10
Model NumberG55804
Catalog NumberULCS-14-30
Lot Number9261777
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
10 2019-05-21

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