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 Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Occupation: materials manager.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 nephro-ureterostomy set was used in an unknown patient for a nephro ureteral stent placement procedure.As reported, ¿the stylet got stuck inside the catheter and would not come out.Another ultrathane cope nephro-ureterostomy set from a different lot number was opened." this first event is recorded under this medwatch report.The operator then experienced the same problem with the second device, recorded under medwatch report #1820334-2019-01098.A third device was opened and used to complete the procedure 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.

Manufacturer Narrative

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, cook received a complaint for the same product experiencing the same failure mode, recorded under medwatch report # 1820334-2019-01100.Physical examination of the complaint device returned in this complaint showed that the stiffener could not be completely inserted through the stent.The stiffener contained kinks, and the tubing was accordioned and elongated just below the hub.The components were measured to be within the correct specifications and tolerances.The investigation concluded that a definitive conclusion could not be made, but the event was likely related to unknown issues during the procedure.Because of the similarities between the two cases, it is likely that the two events have a similar cause.Based on the known information, there is no evidence to suggest the device was not manufactured within the correct specifications and tolerances.Additionally, a document based investigation evaluation was performed.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record for lot 9311821 revealed one relevant nonconformance for occluded catheter, and one device was scrapped out.The stent subassembly lots reported four relevant nonconformances for incorrect length and obstructions.A software search revealed no other complaints have been reported for the complaint device lot 931182.All relevant nonconformance issues are inspected 100% prior to lot release per manufacturing or quality control documentation.Since adequate inspection activities are in place, all relevant nonconforming devices were reworked or scrapped out prior to lot release, and there are not related complaints from the same lot reported from the field, there is no evidence to suggest there is any nonconforming product in house or out in the field.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." the current risk controls in place are adequate to prevent the failure mode from occurring.The analysis indicates that the risks associated with the devices are acceptable when weighed against the benefits.Based on the information provided, no returned product and the results of the investigation, a definitive cause could not be determined.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: 8574161
• MDR Text Key: 144175884
• Report Number: 1820334-2019-01097
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 00827002481763
• UDI-Public: (01)00827002481763(17)211114(10)9311821
• 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: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-8.5-24-NUCL-B-RH
• Device Lot Number: 9311821
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/25/2019
• Initial Date FDA Received: 05/02/2019
• Supplement Dates Manufacturer Received: 06/25/2019
• Supplement Dates FDA Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1