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

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: event occurred sometime in the "last few months".Occupation: unknown.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.

Event Description

It was reported an ultrathane cope nephroureterostomy set was required for a nephroureterostomy tube exchange procedure.During the procedure, the stiffener became stuck in the catheter.This occurred 7 times "over the last few months." the wire also got stuck in the stiffener in most of the incidents.As reported, there were no adverse effects or need for any additional procedures due to this occurrence.

Event Description

Additional information received 07oct202 stated that due to limited stock, the wrong sized nephroureterostomy tube was placed in some cases, but it is unknown if additional visits were required to place a correctly sized tube.No other adverse effects were reported.

Manufacturer Narrative

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

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Additional methods code: device not returned (4114) investigation ¿ evaluation surrey memorial hospital in canada informed cook of seven failed ultrathane cope nephroureterostomy sets.The date of events are unknown, but they occurred over the last few months.The rpn and lot numbers are also unknown.All seven incidents occurred during a catheter exchange where the blue stiffener became stuck inside the catheter.For most incidents, the wire guide also became stuck in the blue stiffener.For all seven incidents, no unintended section of the device remained inside the patient¿s body and there have been no adverse effects to the patient due to these occurrences.It is unknown if the patients required additional procedures.For some of the incidents, the wrong sized catheter was placed in the patient.It is unknown if these patients were brought back for additional visits or if the catheter was used until the next scheduled catheter exchange.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 complainant did not return the complaint devices to cook for investigation.Due to this, no dimensional, visual, or functional verifications could be completed.However, 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 due to lack of lot information from the user facility.A global sales shipment report was conducted from 03sep2017 through 03sep2020 for ultrathane cope nephroureterostomy sets.The customer bought 8 lots over this time period.A complaint database search was completed on these eight lots and no complaints were found.A nonconformance search was completed on these eight lots and there were two potentially related nonconformances both for ¿coating, hc coverage insufficient/irregular¿ that affected a total quantity of four devices 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 and the date of the events occurred in the last few months.Therefore, the unknown lot was likely manufactured prior to implementation activities of the capa.Based on the information provided, no returned product, the fact that the device was likely 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.

• 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: 10579986
• MDR Text Key: 208334351
• Report Number: 1820334-2020-01748
• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1