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

Model Number N/A

Device Problems Difficult to Remove (1528); Stretched (1601)

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

Event Type  malfunction  

Manufacturer Narrative

Occupation: ir supervisor.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 unknown patient required placement of an ultrathane cope nephroureterectomy set for an unknown procedure.Upon removing the stiffening cannula from the catheter, the operator noted the stiffener had stretched where "the blue and yellow part come together" on the device.This event has happened multiple times for multiple physicians.The total number of occurrences is unknown.No other adverse events 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

Additional methods code: communication/interviews (4111).D10 ¿ product received on: 22oct2020.Investigation ¿ evaluation: (b)(6) hospital in the united states informed cook that on 02oct2020, that users had difficulty withdrawing the flexible stiffeners from ultrathane cope nephroureterostomy set drainage catheters.The users placed the device for drainage and when they tried to remove the stiffener, it began to stretch and would not withdraw.The patients did not require additional procedures and did not experience adverse effects.The procedures were completed with new devices.A review of the complaint history, device history record, instructions for use (ifu), and quality control of the device, as well as visual inspection, functional tests, and dimensional verification of the complaint device and additional unused product, were conducted during the investigation.The customer returned one used and four unopened devices.The used device has the flexible stiffener inserted through the catheter, and there is biological matter throughout.The stiffener hub is separated and was not returned.There is no visible damage to catheter.The flexible stiffener was removed from the used catheter with difficulty.The stiffener is kinked and elongated.The four sealed devices were opened and examined.There is no visible damage.Flexible stiffeners were advanced to the tip of the catheters without difficulty and were removed without damage or difficulty.Additionally, a document based investigation evaluation was performed.The catheters are 100% verified for an open lumen.Cook did not identify gaps in the quality control process.The device is shipped with instruction for use (ifu) which provides the following information to the user related to the reported failure mode: "upon removal from package, inspect the product to ensure no damage has occurred." a review of the device history record (dhr) was also conducted as a part of the investigation to check for failure related nonconformances and additional complaints.The dhr for the complaint lot and related subassembly lots did not have failure-related nonconformances.Review of the complaint history for the shows one additional complaint (reported under medwatch report#:1820334-2020-01815).The complaint is from the same user facility and report the same failure of difficult removal of the flexible stiffener from the catheter.The customer returned one used devices to cook for evaluation under the additional complaint.Analysis showed that the catheter inner diameter measured within specification.The stiffener diameter could not be measured due to damage.There is no evidence of nonconforming material from this lot in house or in the field.The device evaluation confirmed that the catheter was manufactured within specification.It is possible that the angle of the patient's anatomy caused resistance during stiffener removal, but this was not confirmed.Based on the information provided, the examination of returned product and the results of the investigation, the cause for this event is component failure without design or manufacturing issue.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

Additional information received 20oct2020: the patient experienced some pain upon removal of stiffener.The event dates are approximately between (b)(6) and (b)(6) 2020.Another similar device was used to complete the procedure.

Manufacturer Narrative

B3: approximate dates were between (b)(6).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: 10680777
• MDR Text Key: 211647866
• Report Number: 1820334-2020-01861
• 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,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/21/2023
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-10.2-24-NUCL-B-RH
• Device Lot Number: 10279176X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1