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

Model Number N/A

Device Problems Difficult to Remove (1528); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/03/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation: unknown.Pma/510(k) #: k1716032.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 an unknown patient required placement of an ultrathane cope nephroureterectomy set for a nephroureterectomy tube exchange procedure.During the procedure, the operator noted the blue stiffener was difficult to remove from the catheter.The wire also was stuck within the stiffener and "telescoping" occurred.Due to the hospital running out of stock of a the same sized tube, a different sized tube was placed to complete the procedure.Once the correct device is in stock, the device will be replaced.No other adverse effects were reported.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.D10 ¿ product received on: 23sep2020 investigation ¿ evaluation (b)(6) hospital in canada informed cook on of an incident involving an ultrathane cope nephroureterostomy set with unknown rpn.On 03sep2020, during a catheter exchange procedure, there was difficulty removing the blue stiffener.The blue stiffener was unable to be removed.The wire was then getting stuck in the blue stiffener.The wire was also unable to be removed.Telescoping occurred and access became lost.No unintended section of the device remained inside the patient¿s body and there have been no adverse effects to the patient due to this occurrence.However, the facility had no more stock on hand, so they had to place in the wrong sized catheter.The patient will be brought back once more stock arrives.From the findings in the device failure analysis section, the rpn was narrowed down to ult8.5-8.5-24-nucl-b-rh.Therefore, the investigation will be completed based on this rpn.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 and dimensional verification, were conducted during the investigation.The complainant returned one used device to cook for investigation.Physical examination of the returned device showed one 8.5fr ult catheter and blue flexible stiffener with biomatter present.There was no visible damage to the catheter.The blue flexible stiffener was returned elongated and the hub is missing.Due to the condition of the returned device, a function test could not be performed.Based on the device markings, sideport locations, and measurements taken, the device rpn was determined to be ult8.5-8.5-24-nucl-b-rh.Additionally, a document based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The risks associated with these devices are acceptable when weighed against the benefits.The device is shipped with instruction for use (ifu) which provides the following information to the user related to the reported failure mode: precautions: "activate hydrophilic coating, if present, by wetting surface of device with sterile water or saline.For best results, maintain wetted condition of device during placement." instructions for use: stent placement "1.Using standard percutaneous access technique, establish wire guide position well into the bladder.5.Over the wire guide, introduce the stent/stiffening cannula into the kidney collecting system.6.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.7.Remove the stiffening cannula from the stent, leaving the wire guide in place.¿ a review of the device history record (dhr) could not be conducted dur to lack of lot information from the user facility.A global sales shipment report was conducted from 03sep2017 through 03sep2020 for the device rpn.The customer bought 4 lots over this time period.Therefore, a dhr review was conducted on these four possible lots.A complaint database search was completed on these four lots and no complaints were found.A nonconformance search was completed on these four lots and there was a potentially related nonconformance with a disposition of scrapped.Cook concluded all other nonconformances are not related to this failure.It was concluded that there is no evidence that nonconforming product exists in house or in field.A capa was previously opened to address this issue.The capa concluded manufacturing related causes and implemented corrective actions.The lot is unknown, but all four potential lots found from a sales history search were manufactured before implementation of corrective actions.Therefore, the complaint lot was manufactured prior to implementation activities of the capa.Based on the information provided, examination of the returned product, the fact that the device was manufactured prior to corrective action implementation, and the results of the investigation, it was determined that a manufacturing and quality control deficiency contributed to this event.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.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.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.

• Brand Name: ULTRATHANE COPE NEPHROURETEROSTOMY SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10579954
• MDR Text Key: 208356168
• Report Number: 1820334-2020-01747
• Device Sequence Number: 1
• Product Code: FAD
• 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,Followup
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1