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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Sepsis (2067); Fungal Infection (2419)
Date of Event	08/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an unknown patient became septic following placement of an ultrathane cope nephroureterostomy set for drainage.The catheter was initially placed on (b)(6) 2023, and a blood draw was done on the same day for testing.On (b)(6) 2023, it was confirmed that the patient had a brewer's yeast infection that later led the patient to become septic.The patient was able to be successfully treated with medication and is reported to be doing better.It was noted that the patient did not have a fungal infection prior to device placement.Additional information regarding event details have been requested but are currently unavailable.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.G4 - 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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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 or Problem Description
In additional information received on 25oct2023, it was reported that the patient was most likely receiving antibiotics prior to the discovery of the fungal infection, but it was not certain.The patient was not immunocompromised; however, the patient was a poorly controlled diabetic.The thought is the uncontrolled diabetes may have contributed to the yeast infection.The patient also had an ileal conduit, and per the physician, the yeast infection may have come from that as well.When the infection was discovered, the patient had a peripheral iv.The patient had been hospitalized for 24 hours prior to placement of the cook device.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: b1 investigation ¿ evaluation it was reported that an unknown patient became septic following placement of an ultrathane cope nephroureterostomy set for drainage.The catheter was initially placed on (b)(6) 2023, and a blood draw was done on the same day for testing.On (b)(6) 2023, it was confirmed that the patient had a brewer's yeast infection that later led the patient to become septic.It was reported that the patient was most likely receiving antibiotics prior to the discovery of the fungal infection, but it was not certain.The patient was not immunocompromised; however, the patient was a poorly controlled diabetic.It was suspected that the uncontrolled diabetes may have contributed to the yeast infection.The patient also had an ileal conduit, and per the physician, the yeast infection may have come from that as well.When the infection was discovered, the patient had a peripheral iv.The patient had been hospitalized for 24 hours prior to placement of the cook device.The patient was able to be successfully treated with medication and is reported to be doing better.No other adverse events were reported.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, specifications, and instructions for use (ifu) of the complaint device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhrs for the reported complaint device lot and the related subassembly lots revealed relevant non-conformances.All nonconforming devices were scrapped prior to further processing of the order.All remaining devices in theses lot underwent 100% verification.Cook reviewed the product labeling.The product ifu, [t_nucl_rev4] [cope nephroureterostomy stent], packaged with the device contains the following in relation to the reported failure mode: "how supplied: supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ the information provided upon review of the dmr, ifu, dhr and returned device 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, no product returned, and the results of the investigation, cook concluded the root cause could not be established.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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 or Problem 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
• Common Device Name: 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: 17701319
• Report Number: 1820334-2023-01205
• Device Sequence Number: 7446501
• Product Code: FAD
• UDI-Device Identifier: 00827002481800
• UDI-Public: (01)00827002481800(17)241022(10)14300337
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/22/2024
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-8.5-26-NUCL-B-RH
• Device Lot Number: 14300337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 10/25/2023; 02/28/2024
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 10/31/2023; 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown