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 11/16/2019

Event Type  Injury  

Manufacturer Narrative

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 a male patient required a catheter exchange of an ultrathane cope nephroureterostomy set.Two days after placement, leaking from the catheter hub was observed.It was also noticed that the "catheter tubing" had separated from the hub.The device was replaced with a new, similar device to complete the procedure.No other adverse effects were reported for this incident.

Event Description

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

Manufacturer Narrative

D10: product received on: (b)(6) 2019.Investigation ¿ evaluation.A customer at (b)(6) hospital (united kingdom) reported that the hub on an ultrathane cope nephroureterostomy set was leaking and separated.The device was placed in the patient on (b)(6) 2019, and hospital staff noticed the leakage and hub separation on (b)(6) 2019.The device was removed and replaced on (b)(6) 2019.The patient did not experience adverse effects.A review of the complaint history, device history record, 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.One 8.5 ult-/-nucl was returned used with the tubing pulled through the hub.There is biological matter throughout.A piece of tape was around the flare.The tape was removed and the flare is undamaged.The hub is connected to tubing by the suture.The suture was cut to get the inner diameter of the connector cap.There is no other damage to the device.There are two (2) adapter threads showing on the hub.The gap between the mac-loc body and connector cap is larger than specification and fails the gap gauge.Cook confirmed the device was manufactured out of specification based on the device failure analysis.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 was reviewed for complaint device lot to check for related nonconformances and additional complaints.There are no failure-related nonconformances recorded for this lot.There are no additional complaints on this lot.An expanded complaint review found no additional complaints on nonconforming product manufactured within a week of the complaint lot.There is no evidence of additional nonconforming material from the complaint lot in house or in the field.There is no evidence that additional lots are affected.The design history file contains testing related to the reported failure.The ifu supplied with the mac-loc drainage catheters instruct that the product should be inspected prior to use to ensure no damage has occurred.Based on the information provided, inspection of returned product and the results of the investigation, it was concluded that the cause of this failure is manufacturing and quality control deficiencies.Corrective actions including implementation of a gap gauge and retraining were performed.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: 9516348
• MDR Text Key: 172599230
• Report Number: 1820334-2019-03161
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 00827002481800
• UDI-Public: (01)00827002481800(17)220814(10)9948481
• 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: 05/05/2020

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 Expiration Date: 08/14/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-8.5-26-NUCL-B-RH
• Device Lot Number: 9948481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Initial Date Manufacturer Received: 11/29/2019
• Initial Date FDA Received: 12/24/2019
• Supplement Dates Manufacturer Received: 05/04/2020
• Supplement Dates FDA Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention