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

Model Number N/A

Device Problems Leak/Splash (1354); Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 11/29/2019

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation: sr.Clinical risk advisor.Report source-other: country of origin: (b)(6), mdip report.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 unknown patient required placement of an ultrathane cope nephroureterostomy set in the bladder, ureter, and kidney for drainage.A day after placement, it was observed the "tube came apart at the tube/hub junction." additionally, the device was leaking because the "tube was dislodged" from the hub.The device was successfully replaced with a new, similar device.No other adverse effects were reported for this incident.

Manufacturer Narrative

Concomitant medical product received on: 13dec2019.Investigation ¿ evaluation.As reported, an unknown patient required placement of an ultrathane cope nephroureterostomy set in the bladder, ureter, and kidney for drainage.A day after placement, it was observed the "tube came apart at the tube/hub junction." additionally, the device was leaking because the "tube was dislodged" from the hub.The device was successfully replaced with a new, similar device.No other adverse events were reported.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection and dimensional verification, were conducted during the investigation.The complaint device was returned used with the hub already separated from the catheter tubing.Biological matter is present throughout the device.The flare appears deformed and damaged; there is a dip/split in the flare.A tug and twist test could not be performed since the tubing was already pulled through the cap.The device passed the measurement specifications between the hub and the cap.Additionally, 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.The device history record (dhr) could not be reviewed due to lack of lot information from the user facility.Review of the sales records to the user facility over the three years prior to the date of event showed nineteen lots.One lot showed one related nonconformance where one device was scrapped due to an inadequate flare.A database search revealed one complaint from one of the nineteen lots found previously at the time of investigation.This complaint concerns an unrelated failure mode.All relevant nonconforming devices were scrapped, and all remaining devices in each lot underwent quality control activities such as tug and twist tests for flare security.Since these 100% inspection procedures are in place and no related complaints have originated from these potential lots, there is no evidence that nonconforming product exists in house or in the field.A capa was previously opened to address this issue and concluded that the main root cause was manufacturing-related.Though the returned device in this complaint was measured within specification for the distance between the hub and cap, it is still possible that a manufacturing-related issue contributed to the event, based on the capa investigation and the unknown date when it was manufactured.Based on the information provided, inspection of the returned product, and the results of the investigation, it was concluded that a manufacturing or quality control deficiency possibly contributed to this incident.The appropriate measures have been conducted to address this failure mode.Retraining of personnel of use a gap gauge device to measure the distance between the hub and the cap has occurred.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.

Event Description

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

• 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: 9460434
• MDR Text Key: 170525477
• Report Number: 1820334-2019-03097
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

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: ULT8.5-8.5-28-NUCL-B-RH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/12/2019
• Supplement Dates Manufacturer Received: 03/24/2020
• Supplement Dates FDA Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention