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

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Occupation: unknown.Pma/510(k) #: preamendment.(b)(4).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 set was used for a nephrostomy procedure in an unknown patient.On (b)(6) 2019, an unspecified amount of time after placement, the device was found leaking "where the drain connects to the hub" and was replaced with another of the same device.The replacement device was also found leaking upon placement.Dermabond was used to glue the connection to stop the leak.No other adverse effects were reported for this incident.The first instance of leakage is captured under the medwatch report with patient identifier (b)(6).The leakage of the replacement device is captured under the medwatch report with patient identifier (b)(6).

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation - evaluation a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a device from the same product family and experiencing the same failure mode was returned under medwatch report #1820334-2019-01684.The examination of the device in this complaint confirmed that there was leakage where the catheter tubing and connector cap met, but there was no evidence to suggest the device was manufactured out of specification.With the known information on the complaint device, there is no evidence to suggest the device was not manufactured within the correct specifications and tolerances.A document based investigation evaluation was performed.The proper procedures are in place to identify and prevent this failure mode prior to device distribution.The risk specifications covering mac-loc drainage catheters include both hub separation and leakage as a potential failure mode.The identified risk controls include manufacturing quality control checks and process validation.The technical files covering mac-loc drainage catheters indicate that the risks associated with these devices are acceptable when weighed against the benefits.A review of the device history record found no related nonconformances with the complaint device lot or subassemblies.A database search revealed one other complaint to have been reported for the same lot.This complaint was also reported for leakage reported by the same facility, for devices used on the same patient.As adequate inspection activities are in place, no related nonconformances were reported, and the related complaint is the only one reported for the same lot, there is no evidence to suggest there is nonconforming product in house or out in the field.Based on the information provided, no examination of returned product and the results of the investigation, a definitive root cause could not be established.Appropriate measures are being conducted 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.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 8932479
• MDR Text Key: 155643355
• Report Number: 1820334-2019-02114
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 00827002481664
• UDI-Public: (01)00827002481664(17)210830(10)9130010
• 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: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-10.2-26-NUCL-B-RH
• Device Lot Number: 9130010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention