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

Model Number N/A

Device Problem Obstruction of Flow (2423)

Patient Problem No Code Available (3191)

Event Date 11/08/2019

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 that a male patient had bilateral ultrathane cope nephroureterostomy set tubes placed during a procedure on (b)(6) 2019.The operator reports that on (b)(6) 2019, the patient required a bilateral nephroureterostomy catheter exchange due to "blockage." the operator reported the tubes "blocked up." the operator reported the upper and lower loops of the catheter were "difficult to unloop due to crud" causing the patient some pain on removal.Due to the blockage, the patient required insertion of new devices.No other adverse effects were reported for this incident.The nephroureterostomy set placed on the left side is capture under medwatch report with patient identifier (b)(6) (this report).The nephroureterostomy set placed on the right side is capture under medwatch report with patient identifier (b)(6).

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.D10 ¿ product received on: (b)(6) 2019.Investigation ¿ evaluation.A customer at (b)(6) reported that an ultrathane cope nephroureterostomy set became blocked soon after placement.The device was placed in the patient's left renal tract on (b)(6) 2019.On (b)(6) 2019, the patient underwent a stent exchange because the device was blocked.The stent was exchanged over a guidewire and 4fr dilator.The device was difficult to remove due to encrusted material on the pigtail loops, which caused the patient pain.The patient had another cope nephroureterostomy catheter previously placed in the right renal tract which experienced the same failure and also required replacement (reported under medwatch report #: 1820334-2019-03029).There was no maintenance protocol for the devices in order to minimize the risk of infection.The patient did not experience any additional adverse effects.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control, and as well as a visual inspection, functional test, and dimensional verification, were conducted during the investigation.One used catheter was returned.There is extensive biological matter present.There is no visible damage.There is a granulated, crusty substance on the outside of the catheter.The proximal loop sideports appear clear.The distal loop sideports are blocked with granulated and encrusted material.A wire guide was inserted through the catheter and met resistance at the proximal loop.The catheter appears brittle at the distal loop.Additionally, a document based investigation evaluation was performed.There are adequate controls in place to address this failure.The device history record for the complaint lot was reviewed to check for related nonconformances and additional complaints.The complaint lot had two applicable nonconformances.All nonconforming devices were scrapped.There are no additional complaints on this lot.The device master record indicates that this device is 100% inspected to verify that the inner lumen is open and the sideports are 100% inspected to ensure that they are cleanly cut.There are adequate inspection activities to capture nonconformances prior to distribution.There is no evidence the complaint device was manufactured out of specification.The instructions for use for the complaint device states: "this product is intended for use by physicians trained and experienced in placement of nephroureterostomy stents.Standard techniques should be employed." there are no known contraindications for placement listed in the ifu.The doctor indicated that they believe the patient's diet has likely caused the stent to become blocked more quickly than in the past.Cook did not identify any design or manufacturing deficiencies in the returned device.Based on the information provided, inspection of returned product and the results of the investigation, it was concluded that a possible cause for this failure is the patient's physiology/diet.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: 9426726
• MDR Text Key: 169593167
• Report Number: 1820334-2019-03026
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 00827002481800
• UDI-Public: (01)00827002481800(17)220529(10)9772051
• 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: 03/24/2020

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: 05/29/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-8.5-26-NUCL-B-RH
• Device Lot Number: 9772051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 03/24/2020
• Supplement Dates FDA Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE- UNKNOWN MANUFACTURER; GUIDE WIRE- UNKNOWN MANUFACTURER
• Patient Outcome(s): Required Intervention