Cook G14095Recalls & reported problems

Cook Incorporated · Percutaneous Pigtail Nephrostomy Set · Class 2

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002140950), received between May 15, 2019 and May 15, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

Material Separation1
Physical Resistance/Sticking1
Unraveled Material1

Patient problems

No Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 15, 2019Material Separation; Unraveled Material; Physical Resistance/Sticking; Material Separation; Unraveled Material; Physical Resistance/Sticking
IT WAS INITIALLY REPORTED ON 19MAR2019, THE REPORTER IS DECLARING A DEFECT WITH THE PERCUTANEOUS PIGTAIL NEPHROSTOMY SET. DURING PERCUTANEOUS PLACEMENT OF A DRAIN IN THE RENAL PELVIS OF A URINOMA THE WIRE GUIDE GOT STUCK INSIDE THE DILATOR. DESPITE REQUESTS FOR ADDITIONAL PATIENT AND EVENT DETAILS, NO FURTHER INFORMATION HAS BEEN PROVIDED. ON 15APR2019, DURING ANALYSIS OF THE RETURNED 10FR PIGTAIL CATHETER AND .038" TEFLON COATED WIRE GUIDE, IT WAS OBSERVED THAT THE GUIDE IS UNRAVELED AND THE SAFETY WIRE IS BROKEN. BASED UPON THE CONDITION OF THE RETURNED DEVICE, THIS EVENT HAS BEEN DETERMINED TO BE A REPORTABLE MALFUNCTION.
Patient problems: No Information
MAUDE report 8612079 ↗

Device details

UDI-DI	`00827002140950`
Brand	Cook
Model	G14095
Catalog no.	080010
Company	Cook Incorporated
Product code	KOB · CATHETER, SUPRAPUBIC (AND ACCESSORIES)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 29, 2018

Device type (GMDN): Nephrostomy catheter

A sterile, flexible tube intended to be inserted percutaneously into the renal pelvis to gain access to the upper urinary tract. This device consists of a large-bore (sizes from 14 to 24 Fr are typical), thin-walled tube usually with a self-retained tip; it sometimes has expanding wings on its tip. It is used to perform drainage for relief of supravesicular obstructions and may also be intended for a variety of procedures of the upper urinary tract including dilation of strictures, removal of calculi, perfusion with chemolytic agents for dissolution of renal stones, or ureteral stenting. This is a single-use device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.