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

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Initial reporter occupation: purchasing.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 a ultrathane cope nephroureterostomy set was used in an unknown patient during a nephroureterostomy.As reported, "inner stylet difficult to insert despite flushing.Once inserted unable to remove from catheter.Resulting in loss of access to patient anatomy." the procedure was completed with another ultrathane cope nephroureterostomy set stent successfully.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Additional information regarding the event and patient outcome has been requested but is currently unavailable.

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 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, functional test, and dimensional verification, were conducted during the investigation.One stent/flexible stiffener combination was returned for investigation.The visual inspection of the complaint device showed the flexible stiffener was partially inserted through the hub of the stent, such that the pigtail remained partially formed.The stiffener was able to be removed with slight resistance.Excessive biomatter was observed to be on the surface of the stiffener.One kink was observed on the stiffener approximately 13 cm from the proximal hub.This likely caused difficult tracking of the catheter/flexible stiffener over the wire guide.The stiffener was also accordioned just below the hub.There was also a region of elongation distal to the kink on the stiffener.An attempt was made to reinsert the stiffener through the catheter tubing.Excessive resistance was encountered and it could not be fully advanced.Dimensional analysis was performed, however, and all components were within the correct specifications and tolerances.Additionally, a document based investigation evaluation was performed.The dhr revealed one related nonconformance for "stiffener kinked".The stent subassembly lots recorded relevant nonconformances for length incorrect and shaft difficult to wire.A software search revealed no other complaints have been reported for the complaint device lot.All relevant nonconformance issues are inspected 100% prior to lot release per manufacturing or quality control documentation.All identified nonconforming devices were reworked or scrapped out prior to lot release.Based on the dhr review, there is no evidence to suggest there is any nonconforming product in house or out in the field.The device's design history files were reviewed.The risks associated with these devices are acceptable when weighed against the benefits.Review of product labeling cook also reviewed product labeling.The product ifu, t_nucl_rev1, provides the following information to the user related to the reported failure mode: instructions for use: stent placement "1.Using standard percutaneous access technique, establish wire guide position well into the bladder.2.Over the wire guide, introduce the stent/stiffening cannula into the kidney collecting system.3.After establishing proper proximal and distal position, push the stent off the stiffening cannula over the wire, making sure the distal pigtail forms within the bladder." how supplied "upon removal from package, inspect the product 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 unknown procedural issues likely contributed to the 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: 8578360
• MDR Text Key: 143999445
• Report Number: 1820334-2019-01100
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 00827002481763
• UDI-Public: (01)00827002481763(17)220115(10)9447758
• 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: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-8.5-24-NUCL-B-RH
• Device Lot Number: 9447758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Initial Date Manufacturer Received: 04/25/2019
• Initial Date FDA Received: 05/03/2019
• Supplement Dates Manufacturer Received: 06/24/2019
• Supplement Dates FDA Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1