MAUDE Adverse Event Report: COOK INC ULTRATHANE COPE NEPHROURETEROSTOMY SET; FAD STENT, URETERAL

Model Number N/A

Device Problems Difficult to Remove (1528); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/23/2022

Event Type  malfunction  

Event Description

A cook ultrathane cope nephroureterostomy set was used for internal/external stent placement for a patient.The device was placed in the right kidney and ureter over a wire.Upon removal, the internal stylet was "getting stuck on the catheter." to remove the device, the physician increased their force.It was at this point that the device separated.No part of the device was left in the patient.No additional procedures were required for this patient.

Manufacturer Narrative

Pma/510(k) #: k171603.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information was provided on 07jul2022.The radiologist properly inserted and positioned the cook ultrathane cope nephroureterectomy set drain over the wire.While holding the drain in place, the radiologist attempted to remove both the light blue flexible stiffener and the guide wire from the cook ultrathane cope nephroureterectomy catheter.During the removal the flexible stiffener began to deform.It first began to deform into an "accordion like" shape.After continued attempts at removal, the flexible stiffener "snapped" while within the catheter.The portion of the stiffener closest to the operator was removed.The doctor then cut the distal end of the catheter in an attempt to retrieve the remaining portion of the flexible stiffener.Upon locating the remaining part of the stiffener, the physician resumed pulling it and it continued to "accordion." the wire and snapped stiffener were able to be removed, however it was noted the structural integrity of the wire guide was compromised due to the catheter having been cut to locate the flexible stiffener.The procedure was completing using a ultrathane cope nephroureterostomy set of a different length.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: b5.Correction: h6- component code.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Investigation ¿ evaluation: on 24may2022, cook medical inc.Received a complaint from mr.(b)(6), a representative at the (b)(6) hospital, located in the city (b)(6).During an internal/external ureteral stent placement, in which the ultrathane cope nephroureterostomy set (rpn: ult8.5-8.5-24-nucl-b-rh, lot: unknown) was used, the flexible stylet became stuck and eventually separated when attempting to remove from the stent.It was confirmed that nothing was left within the patient.No additional harm to the patient has been reported.Reviews of the documentation, including the instructions for use (ifu), manufacturing instructions, quality control procedures and specifications of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examinations could be conducted.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are currently in place to identify this failure mode prior to distribution.A review of the device history record (dhr) could not be completed due to the lack of lot information from the facility.Cook medical performed an expanded sales search from 14may2018 until 14may2022 regarding the reporting facility; however, the complaint lot could not be identified.Cook also reviewed product labeling.Per the attached ifu, t_nucl_rev5, under the heading precautions: it reads, when inserting a stiffening cannula into the catheter with retention suture, hold suture during cannula insertion to avoid bunching or tangling of the suture.Evidence gathered upon review of the dmr and ifu suggests that the device was not manufactured out of specification, and that there are no nonconforming devices in house or out in the field.Based on the information provided, examination of the returned product and the results of our investigation, it was concluded that a component failure unrelated to manufacturing or design deficiencies contributed to the event.The appropriate personnel have been notified.Per the risk assessment no further action is required.We 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 patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: ULTRATHANE COPE NEPHROURETEROSTOMY SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 14644656
• MDR Text Key: 302276231
• Report Number: 1820334-2022-01028
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-8.5-24-NUCL-B-RH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1