MAUDE Adverse Event Report: COOK INC ULTRATHANE COPE NEPHROURETEROSTOMY SET; LJE CATHETER, NEPHROSTOMY

Model Number N/A

Device Problems Fitting Problem (2183); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).Pma/510(k) #: preamendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported an ultrathane cope nephroureterostomy stent was placed in the patient for a nephroureterostomy procedure.As the patient was leaving the facility, the hub fell off of the catheter where the catheter attaches inside the hub.As a result, the device was removed and replaced with another device.The customer noted concern regarding the flare being too small on one side compared to the other side.No other adverse effects were reported for this incident.

Manufacturer Narrative

Investigation - evaluation.A review of the documentation of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.Additionally, a document based investigation evaluation was performed.Inspection activities are in place to prevent the release of nonconforming product related to the reported failure mode.The risk specifications covering mac-loc drainage catheters include both hub separation and leakage as a potential failure mode.The identified risk controls include the manufacturing quality control checks and process validation.The technical files covering mac-loc catheters indicate that the risks associated with these devices are acceptable when weighed against the benefits.A review of the device history record could not be completed because the lot number is unknown.The instructions for use (ifu) advise the user to inspect the product prior to use to ensure that no damage has occurred.Based on the information provided, examination of a similar product evaluation and the results of our investigation, a definitive cause could not be established.Appropriate measures have been taken to address this failure mode.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.

Event Description

No new event description information to report at this time.

• Brand Name: ULTRATHANE COPE NEPHROURETEROSTOMY SET
• Type of Device: LJE CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8006456
• MDR Text Key: 125040464
• Report Number: 1820334-2018-03163
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-10.2-24-NUCL-B-RH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/12/2018
• Initial Date FDA Received: 10/25/2018
• Supplement Dates Manufacturer Received: 12/18/2018
• Supplement Dates FDA Received: 12/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention